FDA Adverse Event
Injury
Summary report: N
PROXIMATE PPH PROCEDURE SET
MDR report key: 1083273
·
Received July 29, 2008
Report
- Report Number
- 3005075853-2008-00749
- Event Type
- Injury
- Date Received
- July 29, 2008
- Date of Event
- June 26, 2008
- Report Date
- July 7, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K051301
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D4, H, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY PROCEDURE, THE DEVICE WAS FIRED, BUT THERE WAS SOME BLEEDING ON THE STAPLE LINE. MANUAL STITCHING WAS DONE TO COMPLETE THE CASE. THE PROCEDURE WAS PROLONGED BY 20 MINUTES. THE PT WAS HOSPITALIZED OVERNIGHT. THE PT WAS DISCHARGED THE FOLLOWING DAY WITH NO APPARENT FURTHER ADVERSE EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE PPH PROCEDURE SET | GDW | ETHICON ENDO-SURGERY, LLC | NA | D4G460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |