FDA Adverse Event
Malfunction
Summary report: N
CHOLECYSTECTOMY TRAY
MDR report key: 6118095
·
Received November 21, 2016
Report
- Report Number
- 1527736-2016-00047
- Event Type
- Malfunction
- Date Received
- November 21, 2016
- Date of Event
- November 7, 2016
- Report Date
- November 8, 2016
- Manufacturer
- ETHICON ENDO SURGERY, INC (CINCINNATI)
- Product Code
- LRO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) DATE SENT: 11/21/2016. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PACKAGING PRESENTS A HOLE, COMPROMISING STERILITY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICES WERE NOT USED ON PATIENT. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 770201 | CHOLECYSTECTOMY TRAY | CHOLECYSTECTOMY TRAY | LRO | ETHICON ENDO SURGERY, INC (CINCINNATI) | NA | N9124W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |