FDA Adverse Event
Malfunction
Summary report: N
NONE
MDR report key: 17015877
·
Received May 28, 2023
Report
- Report Number
- 2955842-2023-14996
- Event Type
- Malfunction
- Date Received
- May 28, 2023
- Date of Event
- August 1, 2022
- Report Date
- August 11, 2022
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- GCJ
- UDI-DI
- 00886874116555
- PMA / PMN Number
- K191736
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 30 DEGREE ENDOSCOPE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED ISSUE. FAILURE ANALYSIS IDENTIFIED PHYSICAL DAMAGE TO IC EMI FINGERS AND ENDOSCOPE BEARING FRICTION ISSUE.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE, THE 30 DEGREE ENDOSCOPE WAS FOUND TO HAVE AN INVERTED IMAGE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1848968 | NONE | ENDOSCOPE PLUS | GCJ | INTUITIVE SURGICAL, INC | 470057-08 | N/A | 00886874116555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |