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

Model Number	470036-03
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/ confirmed 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 the clevis.Root cause of this failure is attributed to a component failure.A review of the site's complaint history does not show any additional complaints related to this product.System logs showed that the instrument was last used on system number (b)(4) on (b)(6) 2020 and it had 8 lives remaining.A review of the submitted image was performed and there is no additional information provided.Based on the information provided at this time, this complaint is being reported because the 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 inside the patient.Although there was no patient injury reported, if this failure were to recur it could cause or contribute to an adverse event.
Event or Problem Description
It was reported that prior to starting a da vinci-assisted radical tonsillectomy surgical procedure, the debakey forceps jaws would not move.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST
• Common Device Name: DEBAKEY FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10955651
• Report Number: 2955842-2020-11307
• Device Sequence Number: 690658
• Product Code: NAY
• UDI-Device Identifier: 00886874112236
• UDI-Public: (01)00886874112236(10)N10180503
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K150284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

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: 470036-03
• Device Catalogue Number: 470036
• Device Lot Number: N10180503 0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/06/2020
• 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