FDA Adverse Event
Malfunction
Summary report: N
ENDOSCOPIC LNR CUTR
MDR report key: 2140577
·
Received June 27, 2011
Report
- Report Number
- 1527736-2011-00142
- Event Type
- Malfunction
- Date Received
- June 27, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 1, 2011
- Manufacturer
- ETHICON ENDO SURGERY, INC (CINCINNATI)
- Product Code
- KOG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE STATUS UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED BY THE OPERATING ROOM NURSE THAT DURING THE NEPHRECTOMY, THE DEVICE WAS STUCK ON THE RENAL VEIN. THE DEVICE FIRED AND STAPLED AND THEN THE JAWS WOULD NOT OPEN. THIS IS THE ONLY INFORMATION KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NO RESPONSE HAS BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOSCOPIC LNR CUTR | STAPLES, IMPLANTABLE | KOG | ETHICON ENDO SURGERY, INC (CINCINNATI) | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |