FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM
MDR report key: 2080038
·
Received May 6, 2011
Report
- Report Number
- 3005075853-2011-01840
- Event Type
- Malfunction
- Date Received
- May 6, 2011
- Date of Event
- April 11, 2011
- Report Date
- May 17, 2024
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- KOG
- PMA / PMN Number
- K940967
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE SURGEON USED THE TRIPLE STAPLE TECHNIQUE USING THE ANCILLARY TROCAR. AFTER PUSHING UP THROUGH THE BOWEL USING A CLAMP, THE ANCILLARY TROCAR SNAPPED IN HALF; THIS HAPPENED TWO TIMES WITH THE DEVICES. THEY USED A THIRD DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM | CIRCULAR STAPLERS | KOG | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNK. |