MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PK DISSECTING FORCEPS

Model Number	420227-11
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pk dissecting forceps instrument was analyzed and the technician did not find any signs of corrosion at the distal end of the instrument.An additional observation not reported by the site that is not related to the customer reported complaint: the instrument was found to have thermal damage on the bipolar yaw pulley.As a result, the electrode was exposed.The instrument passed the electrical continuity test.
Event or Problem Description
It was reported that the pk dissecting forceps front was rusty.There was no report of patient involvement or reported injury.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The pk dissecting forceps had been returned and was evaluated by the advanced failure analysis (afa) team.Afa was performed and completed by engineering.The instrument was inspected under various levels of magnification and the engineer did not find the instrument to exhibit any signs of corrosion or rust at the distal end.The grips were not found to have any damage or irregularities.The cause of the reported customer event was not identified.The following finding was unrelated to the customer reported complaint: afa found the failure of thermal damage on the instrument bipolar yaw pulley.The instrument was found to have thermal damage on one of the two bipolar yaw pulleys.The damage was located at the base of the grip, on the outer surface of the yaw pulley.As a result of the damage, a section of the active electrode on the grip was exposed, which would not normally be exposed.The instrument passed the electrical continuity test.The instrument had 1 remaining use out of 10.A review of the manufacturing history indicated no related nonconformance.It was unclear if the thermal damage observation and the customer reported complaint of rust were related.As the yaw pulley surface containing the thermal damage is not metal and would not rust, the failure was determined to be unrelated.A review of the procedure logs indicated that a monopolar instrument was used during this case.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PK DISSECTING FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 18013022
• Report Number: 2955842-2023-19639
• Device Sequence Number: 7389387
• Product Code: NAY
• UDI-Device Identifier: 00886874111673
• UDI-Public: (01)00886874111673(10)N10201103
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K061260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 420227-11
• Device Catalogue Number: 420227
• Device Lot Number: N10201103 084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown