FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE PPH PROCEDURE SET
MDR report key: 1100005
·
Received August 5, 2008
Report
- Report Number
- 3005075853-2008-00903
- Event Type
- Malfunction
- Date Received
- August 5, 2008
- Date of Event
- July 8, 2008
- Report Date
- July 11, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K051301
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MY
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PPH PROCEDURE, AFTER STAPLING, THE DEVICE COULD NOT BE REMOVED AS A SEGMENT OF THE STAPLE LINE WAS STUCK BETWEEN THE HOUSING AND TISSUE. STAPLE WAS NOT FORMED PROPERLY AT THE 10-12 O'CLOCK POSITION. THE DEVICE WAS REMOVED WITH SOME FORCE CAUSING BLEEDING. PT LOST 10ML OF BLOOD, AND DID NOT REQUIRE A TRANSFUSION. SURGEON THEN SUTURED THE WOUND. PT WAS DISCHARGED AS USUAL WITH NO OTHER ADVERSE EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE PPH PROCEDURE SET | GDW | ETHICON ENDO-SURGERY, LLC | NA | E4L21F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |