MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MONOPOLAR CAUTERY

Model Number	420142-09
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Isi received the monopolar cautery instrument involved with this complaint and completed the device evaluation.Failure analysis investigation replicated/confirmed the reported complaint.The instrument was found to have broken electrical contacts at the distal end.The broken pieces were not returned.The instrument failed the electrical continuity test.The root cause of this failure is attributed to mishandling.Additionally, the instrument was found to have signs of thermal damage to the distal tip, which was unrelated to the primary finding.A review of the site's complaint history does not show any additional reportable complaints related to this product and/or this event.No procedure image or video was provided for review.A review of the instrument log for the instrument (pn 420142-09/lot # t10180606 309) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2021 on system (b)(4) with 1 use remaining.Based on the information provided at this time, this complaint is being reported due to the following conclusion: failure analysis findings revealed that the instrument exhibited signs indicative of thermal damage with no evidence or claim of mishandling or misuse.At this time, it is unknown what caused the thermal damage to occur.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 a da vinci-assisted surgical procedure, the monopolar cautery instrument did not work when used to coagulate.The customer changed the cautery cable, turned the generator off and on, and reconnected the cautery cable with no resolve.The procedure was reportedly completed with no reported injury.Intuitive surgical, inc.(isi) followed up on 20-apr-2021 and 1-jun-2021 and obtained the following additional information: the procedure was completed using a backup instrument with about 20 minutes delay.The procedure delay did not occur during a warm ischemia time.The patient-related information could not be provided.

• Brand Name: ENDOWRIST
• Common Device Name: MONOPOLAR CAUTERY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 11989307
• Report Number: 2955842-2021-10649
• Device Sequence Number: 844935
• Product Code: NAY
• UDI-Device Identifier: 00886874111406
• UDI-Public: (01)00886874111406(10)T10180606
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

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: 420142-09
• Device Catalogue Number: 420142
• Device Lot Number: T10180606 309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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