PROXIMATE ILS Intraluminal Stapler, Endopath ILS Endoscopic Circular Stapler (2019-03-28)
- Starting date:
- March 28, 2019
- Posting date:
- April 12, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-69566
Last updated: 2019-04-12
Affected Products
- PROXIMATE ILS Intraluminal Stapler with detachable head
- Endopath ILS Endoscopic Circular Stapler with low profile anvil
Reason
Through investigation of complaints and returned products, we have confirmed occurrence of uncut washers and malformed staples with our ILS circular staplers, which can compromise staple line integrity. If a problem with the staple line is not adequately addressed or is not recognized, there is a potential risk of postoperative anastomotic leak, gastrointestinal injury, hemorrhage, or hemorrhagic shock.
Affected products
-
PROXIMATE ILS Intraluminal Stapler with detachable head
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
CDH21A
CDH25A
CDH29A
CDH33A
SDH21A
SDH25A
SDH29A
SDH33A
Companies
- Manufacturer
-
ETHICON ENDO-SURGERY, LLC.
475 CALLE C
GUAYNABO
00969
PUERTO RICO
B. Endopath ILS Endoscopic Circular Stapler with low profile anvil
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
ECS21A
ECS25A
ECS29A
ECS33A
Companies
- Manufacturer
-
ETHICON ENDO-SURGERY, LLC.
475 CALLE C
GUAYNABO
00969
PUERTO RICO