FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM
MDR report key: 1132470
·
Received August 22, 2008
Report
- Report Number
- 3005075853-2008-01328
- Event Type
- Malfunction
- Date Received
- August 22, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 21, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- OCW
- PMA / PMN Number
- K940967
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ANVIL WAS VERY LOOSE ON THE TROCAR. WHEN THE SURGEON WOULD TRY TO CLOSE THE DEVICE, THE ANVIL WOULD COME OFF OF THE TROCAR. THEY DID FIRE THE DEVICE AND HAD AN INCOMPLETE STAPLE LINE. THEY EXCISED THE INCOMPLETE STAPLE LINE AND FIRED ANOTHER DEVICE WITH SUCCESS. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE DEVICE WAS DISPOSED OF BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM | OCW | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |