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

Model Number	470171-15
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the micro bipolar forceps involved with this complaint and completed the device evaluation.Failure analysis replicated and confirmed the reported complaint.The instrument was found to have damage to the conductor wire¿s insulation.The insulation does not exhibit thermal damage.The insulation material was lifted; however, no pieces were missing.The conductor wire was slightly exposed; however, the wire was not physically damaged.An electrical continuity test was performed, and the instrument passed.The root cause of this failure was typically attributed to mishandling or misuse, commonly caused by collision with another instrument or sharp object.A review of the device logs for the micro bipolar forceps (part# 470171-15 | lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the micro bipolar forceps was last used on (b)(6) 2022 via system serial# (b)(4).There were 1 use remaining after this last usage.No image or procedure video was provided for review.This complaint is being classified as a reportable event due to the following conclusion: the instrument had conductor wire damage.The damaged/broken conductor wire has potential for electrical discharge at a location other than intended.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that during central processing, the micro bipolar forceps (mbf) had a disconnected wire.There was no report of patient involvement.Isi followed up with the initial reporter and obtained the following additional information: the damaged conductor wire was found after processing.There was no arcing during the last procedure.There was no patient¿s injury.The last procedure was completed robotically.

• 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: 15815730
• Report Number: 2955842-2022-15317
• Device Sequence Number: 17917653
• Product Code: NAY
• UDI-Device Identifier: 00886874112274
• UDI-Public: (01)00886874112274(10)N10180820
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2022

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: 470171-15
• Device Catalogue Number: 470171
• Device Lot Number: N10180820 0040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2018
• 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