ENDOWRIST
Report
- Report Number
- 2955842-2022-10067
- Event Type
- Injury
- Date Received
- January 14, 2022
- Date of Event
- December 15, 2021
- Report Date
- December 16, 2021
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874119778
- PMA / PMN Number
- K150284
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- 003
Narratives
INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE CADIERE FORCEPS INSTRUMENT FOR EVALUATION ALTHOUGH IT HAS BEEN REQUESTED FOR RETURN. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. FURTHERMORE, THE CAUSE OF THE ALLEGED INJURY IS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED AND NO INFORMATION WAS AVAILABLE THAT WOULD PROVIDE INSIGHT AS TO WHAT MAY HAVE OCCURRED. A REVIEW OF THE INSTRUMENT LOGS FOR THE CADIERE FORCEPS ASSOCIATED WITH THIS COMPLAINT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE CADIERE FORCEPS WAS LAST USED ON (B)(6) 2021. THERE WERE 15 USES REMAINING AFTER THIS LAST USAGE. THIS LAST USAGE OF THE DEVICE PER THE LOG REVIEW MATCHES THE REPORTED EVENT DATE, INDICATING THAT THE INSTRUMENT WAS NOT USED AFTER THE DATE OF THE REPORTED EVENT. NO IMAGES OR VIDEO FOOTAGE WAS PROVIDED FOR THIS REPORTED EVENT. A REVIEW OF THE SITE¿S COMPLAINT HISTORY REVEALED NO ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, AN UNSPECIFIED INJURY WAS REPORTED TO HAVE OCCURRED. THE CAUSE, TYPE, AND SEVERITY OF THE INJURY ARE UNKNOWN. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION IN SECTIONS WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION IS NOT APPLICABLE. FIELD IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION IS NOT AVAILABLE FIELDS ARE NOT APPLICABLE.
INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE CADIERE FORCEPS INSTRUMENT FOR EVALUATION ALTHOUGH IT HAS BEEN REQUESTED FOR RETURN. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. FURTHERMORE, THE CAUSE OF THE ALLEGED INJURY IS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED AND NO INFORMATION WAS AVAILABLE THAT WOULD PROVIDE INSIGHT AS TO WHAT MAY HAVE OCCURRED. A REVIEW OF THE INSTRUMENT LOGS FOR THE CADIERE FORCEPS ASSOCIATED WITH THIS COMPLAINT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE CADIERE FORCEPS WAS LAST USED ON (B)(6) 2021. THERE WERE 15 USES REMAINING AFTER THIS LAST USAGE. THIS LAST USAGE OF THE DEVICE PER THE LOG REVIEW MATCHES THE REPORTED EVENT DATE, INDICATING THAT THE INSTRUMENT WAS NOT USED AFTER THE DATE OF THE REPORTED EVENT. NO IMAGES OR VIDEO FOOTAGE WAS PROVIDED FOR THIS REPORTED EVENT. A REVIEW OF THE SITE¿S COMPLAINT HISTORY REVEALED NO ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, AN UNSPECIFIED INJURY WAS REPORTED TO HAVE OCCURRED. THE CAUSE, TYPE, AND SEVERITY OF THE INJURY ARE UNKNOWN. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION IN SECTIONS WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION IS NOT APPLICABLE.
ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: D9, G3, G6, H2, H3, H6, AND H10. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE CARDIERE FORCEPS INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. A VISUAL INSPECTION WAS CONDUCTED AND NO DAMAGE WAS FOUND. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS AND MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED. THE ROOT CAUSE CANNOT BE TRACED TO DEVICE.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, AN UNSPECIFIED INJURY OCCURRED. THE INITIAL REPORTER INDICATED THAT A CADIERE FORCEPS INSTRUMENT WAS DEFECTIVE AND THAT AN INJURY OCCURRED. NO DETAILS WERE PROVIDED REGARDING HOW THE INSTRUMENT WAS DEFECTIVE. ADDITIONALLY, NO DETAILS REGARDING THE PATIENT INJURY WERE PROVIDED. THE CAUSE, SEVERITY, AND TYPE OF INJURY SUSTAINED ARE UNKNOWN. IT IS ALSO UNKNOWN WHAT MEDICAL INTERVENTION, IF ANY, WAS RENDERED DUE TO THE ALLEGED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, AN UNSPECIFIED INJURY OCCURRED. THE INITIAL REPORTER INDICATED THAT A CADIERE FORCEPS INSTRUMENT WAS DEFECTIVE AND THAT AN INJURY OCCURRED. NO DETAILS WERE PROVIDED REGARDING HOW THE INSTRUMENT WAS DEFECTIVE. ADDITIONALLY, NO DETAILS REGARDING THE PATIENT INJURY WERE PROVIDED. THE CAUSE, SEVERITY, AND TYPE OF INJURY SUSTAINED ARE UNKNOWN. IT IS ALSO UNKNOWN WHAT MEDICAL INTERVENTION, IF ANY, WAS RENDERED DUE TO THE ALLEGED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 961186 | ENDOWRIST | CADIERE FORCEPS | NAY | INTUITIVE SURGICAL, INC | 471049-08 | K13210712 0014 | 00886874119778 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |