FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE** SKIN STAPLER 35 REGULAR
MDR report key: 2222596
·
Received August 25, 2011
Report
- Report Number
- 3005075853-2011-03500
- Event Type
- Malfunction
- Date Received
- August 25, 2011
- Date of Event
- August 2, 2011
- Report Date
- August 5, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDT
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Additional Manufacturer Narrative · 1
(B)(4). DEVICE WAS NOT RETURNED. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SIGMOIDECTOMY, THE STAPLE WAS MALFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE** SKIN STAPLER 35 REGULAR | SKIN STAPLER | GDT | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |