MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; SMALL GRASPING RETRACTOR

Model Number	420318-05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the small grasping retractor instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint.The instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was still installed in the clevis.Failure analysis found the primary failure of a broken pitch cable at the distal end of the instrument to be related to the customer reported complaint.Root cause of a broken pitch cable is a component failure.Additional fa findings not reported by the customer: the instrument main tube exhibited signs of scratch marks/abrasions on the distal end.Main tube scratch marks measured roughly 0.03" to 0.29" in length and were not aligned with the tube axis.Material was missing from the surface of the main tube.This failure is most commonly caused by mishandling/misuse, such as excessive contact with abrasive or hard surfaces during transport or reprocessing.Instrument log review: a review of the instrument log for the small grasping retractor (part#420318-05/lot#n10190423 548) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2020 on system (b)(4).The instrument has 10 max allotted uses.On last use it was on its 6th of 10 lives.The alleged event reported on this record could not be confirmed on this review.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No photo or video was provided by the site for review.This complaint is being reported due to the following conclusion: this 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, the product malfunction could cause or contribute to an adverse event if the failure were to recur.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the small grasping retractor was found to have a loose cable.A similar backup instrument was used to proceed with the case.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: SMALL GRASPING RETRACTOR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 11020005
• Report Number: 2955842-2020-11357
• Device Sequence Number: 17042640
• Product Code: NAY
• UDI-Device Identifier: 00886874111802
• UDI-Public: (01)00886874111802(10)N10190423
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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: 420318-05
• Device Catalogue Number: 420318
• Device Lot Number: N10190423 548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 12/16/2020
• 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