FDA Adverse Event
Other
Summary report: N
ENDO5 DISPOSABLE AUTOMATIC APPLIER
MDR report key: 731097
·
Received June 23, 2006
Report
- Report Number
- 3003898360-2006-00005
- Event Type
- Other
- Date Received
- June 23, 2006
- Report Date
- June 23, 2006
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- GDO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TELEFLEX MEDICAL IS CURRENTLY STILL IN THE PROCESS OF OBTAINING THE APPLIER FOR EVALUATION. IF THE APPLIER IS OBTAINABLE FOR AN EVALUATION, TELEFLEX MEDICAL WILL PROVIDE A FOLLOW UP REPORT.
Description of Event or Problem · 1
DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON WAS ATTEMPTING TO REMOVE THE APPLIER FROM THE SURGICAL SITE WHEN THE APPLIER JAW GOT HUNG UP ON THE CANNULA CAUSING ONE OF THE APPLIER JAWS TO FALL OF INTO THE SURGICAL SITE. MINIMAL ADDITIONAL TIME REQUIRED TO RETRIEVE JAW. NO INJURY TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO5 DISPOSABLE AUTOMATIC APPLIER | LIGATION CLIP APPLIER | GDO | TELEFLEX MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |