ENDOWRIST
Report
- Report Number
- 2955842-2022-10625
- Event Type
- Malfunction
- Date Received
- March 16, 2022
- Date of Event
- January 10, 2022
- Report Date
- February 14, 2022
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874112250
- PMA / PMN Number
- K150284
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 003
Narratives
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CADIERE FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FINDING OF THE BROKEN GRIP TIP TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP AT THE GRIP BASE. A PIECE, MEASURING APPROXIMATELY 0.212" X 0.641", WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED WITH THE INSTRUMENT. THE CAUSE OF THE ¿BROKEN INSTRUMENT GRIPS ¿TIPS¿ IS INDICATIVE OF EXCESS FORCE APPLIED TO THE INSTRUMENT JAWS. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) REGULATORY POST MARKET SURVEILLANCE (RPMS) ANALYST. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE IMAGE OF THE CADIERE FORCEPS INSTRUMENT IDENTIFIED THAT THE INSTRUMENT GRIP TIP WAS DETACHED. A REVIEW OF THE INSTRUMENT LOG FOR THE CADIERE FORCEPS INSTRUMENT LOT# N11200224 / SEQUENCE 0020 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED FOR A PROCEDURE ON (B)(6) 2021 USING SYSTEM (B)(4). NO LOGGED USAGE ON THE REPORTED EVENT DATE OF (B)(6) 2022. THE INSTRUMENT HAS 3 REMAINING USABLE LIVES WITH NO SUBSEQUENT USE RECORDED. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: FAILURE ANALYSIS INVESTIGATIONS FOUND THAT A PIECE WAS MISSING FROM THE DISTAL END OF THE INSTRUMENT. THE MISSING PIECE COULD FALL INSIDE THE PATIENT DURING THE SURGICAL PROCEDURE. WHILE THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT, AND IT WAS NOTED THAT NO FRAGMENT FELL INSIDE THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS UNINTENDED FRAGMENT(S) FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION.
INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING THE OPERATION, THE DOCTOR CHECKED THAT NO RESIDUE FELL INTO THE PATIENT'S BODY AND NO FRAGMENT FELL FROM THE DEVICE WHILE IT WAS BEING USED WITHIN A PATIENT WAS REPORTED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER DISCOVERED THE FRONT END OF THE CADIERE FORCEPS INSTRUMENT WAS BROKEN WHILE GRASPING TISSUE. THERE WAS NO REPORT OF ANY FRAGMENTS FALLING INSIDE THE PATIENT. THE CUSTOMER REPLACED THE CADIERE FORCEPS INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 675101 | ENDOWRIST | CADIERE FORCEPS | NAY | INTUITIVE SURGICAL, INC | 470049-07 | N11200224 0020 | 00886874112250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |