FDA Adverse Event
Malfunction
Summary report: N
ENDOWRIST
MDR report key: 21844816
·
Received April 15, 2025
Report
- Report Number
- 2955842-2025-14937
- Event Type
- Malfunction
- Date Received
- April 15, 2025
- Date of Event
- March 21, 2025
- Report Date
- March 21, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K214095
- Removal / Correction Number
- ISIFA2024-09-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE INSTRUMENT INVOLVED IN THIS COMPLAINT HAS BEEN RECEIVED AND TESTED BY FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE A DAMAGED GRIP CABLE.
Additional Manufacturer Narrative · 0
PRIMARY PRODUCT BATCH/LOT NUMBER UNDER SECTION D WAS UPDATED TO K12230608 0005. ANNEX A CODE WAS UPDATED TO A040605 BASED ON THE SYMPTOM CODE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS A FRAYED CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: "THE REASON FOR THE RETURN IS DUE TO THE CABLE FRAY."
Description of Event or Problem · 0
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134368 | ENDOWRIST | CADIERE FORCEPS | NAY | INTUITIVE SURGICAL, INC | 471049-08 | K12230608 0005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |