FDA Adverse Event
Injury
Summary report: N
ENDOWRIST
MDR report key: 21157515
·
Received January 15, 2025
Report
- Report Number
- 2955842-2024-24074
- Event Type
- Injury
- Date Received
- January 15, 2025
- Date of Event
- November 25, 2024
- Report Date
- December 19, 2024
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K214095
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM APPLYING EXCESS FORCE ON THE INSTRUMENT SHAFTS AND/OR TIPS DURING HANDLING, INSERTION, USAGE (OVERLOADING), OR REMOVAL.
Additional Manufacturer Narrative · 0
INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT FOR FAILURE ANALYSIS EVALUATION.
Description of Event or Problem · 0
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Description of Event or Problem · 0
ON 20-DEC-2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5163125 STATING: "DAVINCI MEGA SUTURECUT NEEDLE DRIVER 8MM, ONE OF THE GRABBERS BROKE APART INSIDE OF PATIENT DURING A ROUX ENY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1274371 | ENDOWRIST | MEGA SUTURECUT ND | NAY | INTUITIVE SURGICAL, INC | 471309-16 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | Required Intervention | DA VINCI INSTRUMENTS AND ACCESSORIES. |