ENDOWRIST
Report
- Report Number
- 2955842-2024-14653
- Event Type
- Malfunction
- Date Received
- May 23, 2024
- Date of Event
- April 17, 2024
- Report Date
- April 29, 2024
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874120767
- PMA / PMN Number
- K214095
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
INTUITIVE SURGICAL INC (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION.
FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BENT GRIPS TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BENT GRIP, CAUSING VERTICAL MISALIGNMENT OF THE GRIPS. THERE WAS A PORTION OF THE GRIP NEAR THE BASE, CLOSEST TO DISTAL CLEVIS PIN THAT EXTENDED FURTHER THAN MANUFACTURED. THE INSTRUMENT WAS FOUND TO HAVE A SEGMENT OF THE CONDUCTOR WIRE DISLODGED IN THE DISTAL CLEVIS. A LOOP OF WIRE IS LODGED BETWEEN THE GRIPS LIKELY CAUSING THE GRIPS TO BE MISALIGNED. THE WIRE INSULATION WAS NOT DAMAGED, AND THE INSTRUMENT PASSED AN ELECTRICAL CONTINUITY TEST.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT HAD AN ISSUE WHEN DISSECTING TISSUE. THE INSTRUMENT WOULD LOCK DOWN AND THE SITE WAS UNABLE TO RELEASE THE TISSUE AS THE HINGE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9833 | ENDOWRIST | FORCE BIPOLAR | NAY | INTUITIVE SURGICAL, INC | 471405-06 | K10230914 0393 | 00886874120767 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose | DA VINCI INSTRUMENTS AND ACCESSORIES. |