FDA Adverse Event
Malfunction
Summary report: N
ENDOLOOP LIGATURE WITH PDS II
MDR report key: 3871648
·
Received June 13, 2014
Report
- Report Number
- 2210968-2014-07563
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Date of Event
- May 19, 2014
- Report Date
- May 20, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- GCJ
- PMA / PMN Number
- K925914
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON 05/19/2014 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE BROKE. A LIKE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350816 | ENDOLOOP LIGATURE WITH PDS II | LAPROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |