MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MEDIUM-LARGE CLIP APPLIER

Model Number	430005-52
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted thyroidectomy surgical procedure, the single-port medium-large clip applier instrument was found to have broken cables.There was no report that the instrument had clip application issues.A backup instrument of the same kind was used to continue the procedure.There was no report of fragment(s) falling inside the patient.The procedure was completed with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no abnormality.No functional issue on the clip applier instrument reported during intraoperative use.The customer confirmed that no fragment fell inside of the patient.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting broken cable, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The single-port (sp) medium-large clip applier instrument was analyzed and found to have a broken snake wrist cable at the distal end.The broken cable segment that contains the crimp was missing.Common causes of the failure mode are attributed to a component failure.Cable breakage, whether partial or full, may be attributed to reduction in ultimate strength of the material, which may be the result of damage to the cable through external collisions, during use, or during reprocessing.The complaint regarding broken cable was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.This event is considered a reportable malfunction due to the following conclusion: failure analysis found the sp medium-large clip applier instrument to have a broken snake wrist cable at the distal end.The broken cable segment that contains the crimp was missing.If a snake wrist cable breaks at the distal end, a cable segment and/or the crimp could potentially fall inside a patient.Although there was no patient injury reported, a recurrence of the failure mode could cause or contribute to an adverse event.

• Brand Name: ENDOWRIST SP
• Common Device Name: MEDIUM-LARGE CLIP APPLIER
• 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: 16616322
• Report Number: 2955842-2023-11537
• Device Sequence Number: 20038151
• Product Code: NAY
• UDI-Device Identifier: 00886874114292
• UDI-Public: (01)00886874114292(10)S10200109
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2023

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: 430005-52
• Device Catalogue Number: 430005
• Device Lot Number: S10200109 0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2023
• Initial Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2020
• 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