FDA Adverse Event
Malfunction
Summary report: N
RELIACATCH
MDR report key: 7144002
·
Received December 22, 2017
Report
- Report Number
- 2936999-2017-05705
- Event Type
- Malfunction
- Date Received
- December 22, 2017
- Date of Event
- December 7, 2017
- Report Date
- April 16, 2018
- Manufacturer
- CELESTICA ELECTRONICS S PTE LTD
- Product Code
- GCJ
- UDI-DI
- 10884521704046
- PMA / PMN Number
- K163102
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE REMOVING THE GALL BLADDER, THE UNIT'S BAG BROKE AND RIPPED. NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 921633 | RELIACATCH | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | CELESTICA ELECTRONICS S PTE LTD | CATCH10 | C1050117A | 10884521704046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |