ENDOWRIST
Report
- Report Number
- 2955842-2021-11556
- Event Type
- Injury
- Date Received
- November 21, 2021
- Date of Event
- October 27, 2021
- Report Date
- October 28, 2021
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874112441
- PMA / PMN Number
- K131861
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED/REPLICATED THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN MAIN TUBE AT THE DISTAL END. MATERIAL, APPROXIMATELY 0.08" X 0.05" APPEARED TO BE MISSING AT THE END OF THE SHAFT, WHERE IT JOINS WITH THE PROXIMAL CLEVIS. WRIST ASSEMBLY WAS NO LONGER STRAIGHT DUE TO THE DAMAGE. THE KNOWN COMMON CAUSE OF THIS FAILURE IS MISHANDLING/MISUSE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE INSTRUMENT LOG FOR THE SMALL GRASPING RETRACTOR INSTRUMENT (PART NUMBER: 470318-10, LOT NUMBER: N10201130-0134) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2021 ON SYSTEM (B)(4). THE INSTRUMENT WAS USED FOR 7 MINUTES. THE INSTRUMENT HAD 5 USES REMAINING OUT OF 10 MAXIMUM USES. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT THE SMALL GRASPING RETRACTOR INSTRUMENT BROKE AND FRAGMENTS FELL INSIDE THE PATIENT DURING A DA VINCI ASSISTED PROCEDURE. IT WAS NOTED THAT ALL VISIBLE FRAGMENTS WERE RETRIEVED, BUT THAT THE INSTRUMENT HAD SPLINTERED SO THAT IT WAS IMPOSSIBLE TO KNOW IF ALL FRAGMENTS WERE RETRIEVED. IT REMAINS UNKNOWN IF FRAGMENTS FROM THE INSTRUMENT BREAKAGE WERE RETAINED INSIDE THE PATIENT'S ANATOMY. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA.
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED/REPLICATED THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN MAIN TUBE AT THE DISTAL END. MATERIAL, APPROXIMATELY 0.08" X 0.05" APPEARED TO BE MISSING AT THE END OF THE SHAFT, WHERE IT JOINS WITH THE PROXIMAL CLEVIS. WRIST ASSEMBLY WAS NO LONGER STRAIGHT DUE TO THE DAMAGE. THE KNOWN COMMON CAUSE OF THIS FAILURE IS MISHANDLING/MISUSE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE INSTRUMENT LOG FOR THE SMALL GRASPING RETRACTOR INSTRUMENT (PART NUMBER: 470318-10, LOT NUMBER: N10201130-0134) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2021 ON SYSTEM (B)(4). THE INSTRUMENT WAS USED FOR 7 MINUTES. THE INSTRUMENT HAD 5 USES REMAINING OUT OF 10 MAXIMUM USES. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT THE SMALL GRASPING RETRACTOR INSTRUMENT BROKE AND FRAGMENTS FELL INSIDE THE PATIENT DURING A DA VINCI ASSISTED PROCEDURE. IT WAS NOTED THAT ALL VISIBLE FRAGMENTS WERE RETRIEVED, BUT THAT THE INSTRUMENT HAD SPLINTERED SO THAT IT WAS IMPOSSIBLE TO KNOW IF ALL FRAGMENTS WERE RETRIEVED. IT REMAINS UNKNOWN IF FRAGMENTS FROM THE INSTRUMENT BREAKAGE WERE RETAINED INSIDE THE PATIENT'S ANATOMY. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED COLORECTAL SURGICAL PROCEDURE, THE SMALL GRASPING RETRACTOR SPLINTERED AT THE METAL TO THE FIBERGLASS SHAFT JOINT. THE BROKEN PIECE WAS RETRIEVED DURING THE PROCEDURE. THE CUSTOMER USED A BACKUP INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER (A NURSE) AND OBTAINED ADDITIONAL INFORMATION ON 02-NOV-2021. ALL VISIBLE FRAGMENTS WERE RETRIEVED, BUT IT WAS IMPOSSIBLE TO KNOW IF ALL FRAGMENTS WERE RETRIEVED BECAUSE THE INSTRUMENT SPLINTERED UNDER THE METAL JOINT. DUE TO THE SHAFT BEING RADIOPAQUE, POST-OPERATIVE TESTS WERE NOT PERFORMED. THE REPORTED ISSUE HAPPENED BEHIND THE CAMERA, SO THERE WAS NO PROCEDURE VIDEO AVAILABLE. THE INSTRUMENT HAD BEEN USED FOR SEVERAL HOURS AND HAD BEEN INSPECTED PRIOR TO USE WITH NO DAMAGE NOTED. THE SURGEON WAS GRASPING AND MANIPULATING THE BOWEL WHEN THE REPORTED ISSUE OCCURRED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT, AND IT DID NOT COLLIDE WITH OTHER INSTRUMENTS OR OTHER HARD MATERIAL. SINCE THE INSTRUMENT WAS DAMAGED AND STUCK INSIDE THE CANNULA, BOTH UNITS HAD TO BE FORCEFULLY REMOVED FROM THE PATIENT. IT WAS UNKNOWN IF THE PATIENT HAD RETURNED DUE TO COMPLICATIONS FROM RETAINING A FOREIGN OBJECT. ON 09-NOV-2021, ISI RECEIVED USER FACILITY REPORT (B)(4) STATING THE FOLLOWING: "ONE OF THE DAVINCI SMALL GRASPING RETRACTORS SHEERED/BROKE WHILE IN USE DURING A ROBOTIC-ASSISTED SUBTOTAL COLECTOMY."
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED COLORECTAL SURGICAL PROCEDURE, THE SMALL GRASPING RETRACTOR SPLINTERED AT THE METAL TO THE FIBERGLASS SHAFT JOINT. THE BROKEN PIECE WAS RETRIEVED DURING THE PROCEDURE. THE CUSTOMER USED A BACKUP INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER (A NURSE) AND OBTAINED ADDITIONAL INFORMATION ON 02-NOV-2021. ALL VISIBLE FRAGMENTS WERE RETRIEVED, BUT IT WAS IMPOSSIBLE TO KNOW IF ALL FRAGMENTS WERE RETRIEVED BECAUSE THE INSTRUMENT SPLINTERED UNDER THE METAL JOINT. DUE TO THE SHAFT BEING RADIOPAQUE, POST-OPERATIVE TESTS WERE NOT PERFORMED. THE REPORTED ISSUE HAPPENED BEHIND THE CAMERA, SO THERE WAS NO PROCEDURE VIDEO AVAILABLE. THE INSTRUMENT HAD BEEN USED FOR SEVERAL HOURS AND HAD BEEN INSPECTED PRIOR TO USE WITH NO DAMAGE NOTED. THE SURGEON WAS GRASPING AND MANIPULATING THE BOWEL WHEN THE REPORTED ISSUE OCCURRED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT, AND IT DID NOT COLLIDE WITH OTHER INSTRUMENTS OR OTHER HARD MATERIAL. SINCE THE INSTRUMENT WAS DAMAGED AND STUCK INSIDE THE CANNULA, BOTH UNITS HAD TO BE FORCEFULLY REMOVED FROM THE PATIENT. IT WAS UNKNOWN IF THE PATIENT HAD RETURNED DUE TO COMPLICATIONS FROM RETAINING A FOREIGN OBJECT. ON 09-NOV-2021, ISI RECEIVED USER FACILITY REPORT (B)(4) STATING THE FOLLOWING: "ONE OF THE DAVINCI SMALL GRASPING RETRACTORS SHEERED/BROKE WHILE IN USE DURING A ROBOTIC-ASSISTED SUBTOTAL COLECTOMY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1747847 | ENDOWRIST | SMALL GRASPING RETRACTOR | NAY | INTUITIVE SURGICAL, INC | 470318-10 | N10201130 0134 | 00886874112441 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | DA VINCI INSTRUMENTS AND ACCESSORIES |