FDA Adverse Event
Malfunction
Summary report: N
RELIACATCH
MDR report key: 11746762
·
Received April 29, 2021
Report
- Report Number
- 2936999-2021-00387
- Event Type
- Malfunction
- Date Received
- April 29, 2021
- Date of Event
- April 12, 2021
- Report Date
- April 29, 2021
- 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
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
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, AT COMPLETION OF ROBOTIC LOBECTOMY, SPECIMEN (LOBE) WAS PLACED IN BAG AND DURING REMOVAL OF BAG AND SPECIMEN FROM THE CHEST, THE BAG TORE. NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 643335 | RELIACATCH | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | CELESTICA ELECTRONICS S PTE LTD | CATCH10 | C1091320A | 10884521704046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |