FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH BLUNT CHERRY DISSECTOR
MDR report key: 206383
·
Received January 13, 1999
Report
- Report Number
- 1527736-1999-00192
- Event Type
- Malfunction
- Date Received
- January 13, 1999
- Date of Event
- December 7, 1998
- Report Date
- December 7, 1998
- Manufacturer
- CARWILD CORPORATION
- Product Code
- KNS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THREE DEVICES WERE USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. IT WAS REPORTED BY THE AFFILIATE THAT WHEN DISSECTING WITH THE BCD10 INSTRUMENTS (THREE), THE COTTON WAS LOOSE AND FELL OFF INTO THE PT. THE SURGEON WASN'T COMPLETELY SURE THAT ALL OF THE COTTON WAS FOUND AND RETRIEVED. NO SHARP INSTRUMENT WAS USED AT THE SAME TIME AS THE CHERRY DISSECTORS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH BLUNT CHERRY DISSECTOR | INSTRUMENTS - ENDOSCOPIC | KNS | CARWILD CORPORATION | NA | L4C65D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |