FDA Adverse Event
Malfunction
Summary report: N
LCS COAGULATING SCALPEL
MDR report key: 57681
·
Received October 4, 1996
Report
- Report Number
- 1222781-1996-00006
- Event Type
- Malfunction
- Date Received
- October 4, 1996
- Date of Event
- September 5, 1996
- Report Date
- October 4, 1996
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- KNS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A1,2,3,4;B6,7;D10: INFORMATION UNAVAILABLE. 9/16/96 1505 MESSAGE AND 800# LEFT WITH FOR MD CALL BACK. KJB. 9/17/96 NNCL SENT. KJB. 10/4/96 REP ADVISED THAT THE HOSPITAL WILL BE KEEPING THE PRODUCT. REA. RPO. D5,6;H4,6: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING A LAPAROSCOPY PROCEDURE. AFTER THE PROCEDURE, THE SCRUB NURSE WAS ATTEMPTING TO REMOVE THE SCALPEL FROM THE HAND PIECE WITH THE WRENCH WHEN THE TOP PORTION OF THE BLADE TIP SEPARATED FROM THE SHAFT. THE SCRUB NURSE THEN REMOVED THE BLADE SHAFT FROM THE HAND PIECE. THERE WAS NO CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LCS COAGULATING SCALPEL | COAGULATING SCALPEL | KNS | ETHICON ENDO-SURGERY, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |