FDA Adverse Event
Malfunction
Summary report: N
ROTATING MULTIPLE CLIP APPLIER
MDR report key: 2073025
·
Received April 29, 2011
Report
- Report Number
- 3005075853-2011-01795
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- March 2, 2011
- Report Date
- April 8, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- FZP
- PMA / PMN Number
- K864102
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.
Additional Manufacturer Narrative · 1
(B)(4) 2011. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH THE SHAFT NOT PROPERLY CRIMPED, CAUSING THAT THE SHROUD SUBASSEMBLY LOSES ITS INTENDED POSITION IN RELATION TO THE SHAFT. DUE TO THIS CONDITION, SHORT FEED ISSUES WERE NOTED DURING FIRING LEADING CLIPS WITH GAP. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.
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 CHOLECYSTECTOMY PROCEDURE, THE CLIPS WOULD NOT HOLD AFTER PLACING. NO MORE DETAIL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ROTATING MULTIPLE CLIP APPLIER | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | G4U96Y |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |