FDA Adverse Event
Malfunction
Summary report: N
NONE
MDR report key: 17067256
·
Received June 5, 2023
Report
- Report Number
- 2955842-2023-15678
- Event Type
- Malfunction
- Date Received
- June 5, 2023
- Date of Event
- April 14, 2022
- Report Date
- April 22, 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
- AZ, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENDOSCOPE PLUS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS DID NOT CONFIRM THE CUSTOMER COMPLAINT. HOWEVER, THERE WAS VISUAL DAMAGE TO THE CABLE, DISCOLORATION OF IC HOUSING, AND LASER MARKING ON THE HOUSING. .
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE PLUS IMAGE FLIPPED BACK AND FORTH. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1021275 | NONE | ENDOSCOPE PLUS | GCJ | INTUITIVE SURGICAL, INC | 470057-05 | N/A | 00886874116555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |