MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MICRO BIPOLAR FORCEPS

Model Number	471171-15
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Energy Output Problem (1431); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The micro bipolar forceps instrument was analyzed.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.Performed energy delivery with no issue.The instrument was retested and passed all functional test on multiple attempts.The instrument was fully functional.No product issue was identified.Additionally, the instrument was found to have thermal damage on bipolar yaw pulley.The instrument was found to have exposed electrode on one of the bases of the bipolar forceps grip.The unit passed electrical continuity test.The instrument was also found to have damage of the conductor wire¿s insulation.The conductor wire was found nicked with no exposed internal wire.There was no missing piece of the insulation.The instrument passed electrical continuity test.The instrument was found to have scratch marks/abrasions on the edge of the bipolar yaw pulley.The scratch marks/abrasions were found on one side of the bipolar yaw pulley.The complaint was not confirmed by failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the micro bipolar forceps instrument was not delivering energy consistently and not cauterizing.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer noted no thermal damage was observed.No arcing was observed during the procedure.No sparking, smoke occurred during procedure.No patient injury or adverse event during or after surgical procedure.It is unsure if there are any photographic images of the device(s) or a video recording of the procedure available for isi review.The instrument was inspected prior to use and no damage or anything out of the ordinary.There was no thermal damage observed.To their knowledge, there was no instrument collision with an energy instrument during the procedure.

• Brand Name: ENDOWRIST
• Common Device Name: MICRO BIPOLAR 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: 18381280
• Report Number: 2955842-2023-20958
• Device Sequence Number: 7766983
• Product Code: NAY
• UDI-Device Identifier: 00886874121474
• UDI-Public: (01)00886874121474(10)K11220208
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K214095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2023

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: 471171-15
• Device Catalogue Number: 471171
• Device Lot Number: K11220208 0266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• 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