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

Model Number	470036-04
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the 8mm debakey forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed/replicated the customer reported complaint.Fa found the primary failure of broken pitch cable to be related to the customer reported complaint.The debakey forceps instrument was found to have a broken pitch cable at the distal end.The broken cable segment that contains the crimp was missing from clevis.The pitch cable breakage occurs when tensile load exceeds the ultimate strength of the material.The pitch cable construction is designed to optimize load and fatigue (cycling) characteristics.Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables which can influence pitch cable failure.The root cause of the broken pitch cable was attributed to a component failure and related to device design.Additional observation(s) not reported by site were also identified: the debakey forceps instrument was found to have various scratch marks on the main tube.The scratch marks were 0.097¿ - 0.194¿ in length and were not aligned with the tube axis.The root cause of the scratch marks /abrasions on the instrument main tube is typically attributed to mishandling/misuse.No image or video of the last procedure was provided for review.A review of the instrument log for the debakey forceps (470036-04/n10181217 0019) associated with this event has been performed.Per logs, the debakey forceps instrument was last used on (b)(6) 2022 on system (b)(4).The alleged instrument had 4 uses remaining after the last procedural use.This complaint is reportable malfunction event based on the failure analysis findings.This debakey forceps instrument is designed with two pitch cables each with a crimp at the distal end.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall into the patient.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 tongue base resection - benign surgical procedure, the debakey forceps instrument had a broken cable.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: ENDOWRIST
• Common Device Name: DEBAKEY 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: 15158037
• Report Number: 2955842-2022-13316
• Device Sequence Number: 20135693
• Product Code: NAY
• UDI-Device Identifier: 00886874112236
• UDI-Public: (01)00886874112236(10)N10181217
• Combination Product (Y/N): N
• PMA/510(K) Number: K150284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

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: 470036-04
• Device Catalogue Number: 470036
• Device Lot Number: N10181217 0019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2018
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian