FDA Adverse Event
Injury
Summary report: N
ENDOWRIST
MDR report key: 21694025
·
Received March 25, 2025
Report
- Report Number
- 2955842-2025-09954
- Event Type
- Injury
- Date Received
- March 25, 2025
- Date of Event
- February 26, 2025
- Report Date
- February 26, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K131861
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE PERMANENT CAUTERY HOOK INSTRUMENT FOR FAILURE ANALYSIS EVALUATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE TIP BROKE OFF A PERMANENT CAUTERY HOOK INSTRUMENT. A FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE CUSTOMER REPLACED THE INSTRUMENT AND WAS CONTINUING WITH THE PROCEDURE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) VIEWED SYSTEM LOGS AND DID NOT FIND ANY ERRORS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2099093 | ENDOWRIST | PERMANENT CAUTERY HOOK | NAY | INTUITIVE SURGICAL, INC | 470183 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | DA VINCI INSTRUMENTS AND ACCESSORIES |