FDA Adverse Event
Injury
Summary report: N
PROXIMATE CIRCULAR STAPLER
MDR report key: 4152018
·
Received October 8, 2014
Report
- Report Number
- 3005075853-2014-06790
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- September 11, 2014
- Report Date
- September 17, 2014
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K983536
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A RECTOSIGMOIDECTOMY FOR SIGMOID DIVERTICULAR DISEASE PROCEDURE, WHEN WE USE THE DEVICE, THE CIRCULAR STAPLER LINEAR CUTTING 75. ON THIS OCCASION THE RINGS WERE INTACT AND OPERATING THE TIRE FITTER WAS POSITIVE. THE PATIENT DEVELOPED FISTULA IN COLORECTAL ANASTOMOSIS IN THE SEVENTH POSTOPERATIVE DAY WHEN WE FOUND THE PARTIAL DEHISCENCE WITH FECES IN THE PELVIC CAVITY. A TEMPORARY COLOSTOMY WAS MADE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ONE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632632 | PROXIMATE CIRCULAR STAPLER | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | NA | L4EF7H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |