NONE
Report
- Report Number
- 2955842-2022-10610
- Event Type
- Malfunction
- Date Received
- March 15, 2022
- Date of Event
- February 9, 2022
- Report Date
- February 13, 2022
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 10886874111045
- PMA / PMN Number
- K112263
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF "TIP COVER WAS MELTED AND CUSTOMER USED BACK UP TIP COVER FOR THE PROCEDURE. PIC IS ATTACHED". THE TIP COVER WAS FOUND WITH A HOLE STARTING AT THE SILICON OVERMOLD OF THE TIP COVER ON THE BODY OF THE TIP COVER, MEASURING APPROXIMATELY 0.15¿ X 0.35¿. DAMAGE APPEARED TO BE A CRATER-LIKE HOLE. THE HOLE ALSO EXHIBITED CHAR LIKE FEATURES AT THE AFFECTED AREA. ANY MATERIAL MISSING IS LIKELY TO BE THERMALLY INDUCED RATHER THAN MECHANICALLY INDUCED. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF TIP COVER - THERMAL DAMAGE TO BE RELATED THE CUSTOMER REPORTED COMPLAINT. THE ROOT CAUSE OF THERMAL DAMAGE TIP COVER-ACCESSORY IS TYPICALLY ATTRIBUTED TO USER MISHANDLING/MISUSE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. IN ADDITION, THE UNIT IS AN ACCESSORY AND DOES NOT GET CAPTURED BY SYSTEM LOGS. THEREFORE, AN INSTRUMENT LOG REVIEW OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED. HOWEVER, A REVIEW OF THE INSTRUMENT LOG IDENTIFIES THE MONOPOLAR CURVED SCISSORS (PART # 470179-19/LOT# K10211026-0249) ASSOCIATED WITH THIS EVENT. THE INSTRUMENT WAS USED ON (B)(6) 2022, DURING AN ATRIAL SEPTAL DEFECT REPAIR PERFORMED BY CONSOLE SURGEON (B)(6) VIA SYSTEM SERIAL# (B)(4). THE INSTRUMENT HAD 6 USES REMAINING AFTER THIS. THE INSTRUMENT WAS ON ITS LAST USE ON (B)(6) 2022 ON SYSTEM SL0093. REVIEW OF THE PROVIDED IMAGE IS CONSISTENT WITH THE COMPLAINT OF MELTED TIP COVER. IT WAS ALLEGED THAT THE MCS TIP COVER ACCESSORY WAS DAMAGED DUE TO ARCING AND HAD HOLES AND MISSING MATERIAL ON THE GRAY SILICONE AREA. IN THE EVENT THE TIP COVER IS COMPROMISED, IT IS POSSIBLE FOR ENERGY TO DISCHARGE IN AN AREA OTHER THAN THE INSTRUMENT TIP. PER THE I&A USER MANUAL "IT IS IMPORTANT TO EXERCISE CAUTION WHEN USING A ENERGIZED ENDOWRIST MONOPOLAR CURVED SCISSORS INSTRUMENT TO HELP AVOID UNINTENDED CONTACT WITH TISSUE ADJACENT TO THE AREA TO BE CAUTERIZED." FAILURE TO FOLLOW THESE PRECAUTIONS WILL RESULT IN ELECTRICAL ARCS FROM THE WRIST AND ALTERNATE SITE BURNS. 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. IMPLANT DATE IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. PMA/510K AND ADVERSE EVENT ARE NOT APPLICABLE.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS MELTED. ANOTHER PART WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS CONTINUING AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING A DA VINCI-ASSISTED CARDIAC SURGICAL PROCEDURE, ARCING INVOLVING AN MCS INSTRUMENT OCCURRED WHILE THE INSTRUMENT TIP COLLIDED WITH ANOTHER INSTRUMENT. THERE WAS NO PATIENT INJURY/HARM. THE INITIAL REPORTER COULD NOT PROVIDE FURTHER DETAILS AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601747 | NONE | TIP COVER ACCESSORY | NAY | INTUITIVE SURGICAL, INC | 400180-14 | M90210713 0010 | 10886874111045 |