MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; LARGE HEM-O-LOK CLIP APPLIER

Model Number	420230-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2020
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 confirmed the customer reported complaint.The large clip applier instrument was found to have a loose grip cable at the distal end.The instrument was found to have a broken grip cable at the proximal end (in the housing).As a result, loose grip cables are observed at the distal end.This failure is most commonly caused by mishandling/misuse, such as incorrect chemical concentrations during reprocessing.Signs of corrosion were found on the instrument bearings.Pitch and grip input disk bearings exhibited orange discoloration.Improper cleaning during reprocessing most commonly causes this failure.The instrument was found to have an excessive amount of dried residue around the clamping pulley cable grooves.This failure is most commonly caused by improper reprocessing, such as insufficient flushing.A review of the instrument log for the clip applier (pn:420230-10/lot# n10190125 977) has been performed.Per logs, it was confirmed the instrument was last used during a procedure on system (b)(4) on communicated event date of (b)(6) 2020 and had 45 lives remaining.Based on the information provided at this time, this complaint is being classified as a reportable malfunction event due to the following conclusion: the endowrist large clip applier is intended to be used with the da vinci system for the application of large weck hem-o-lok polymer locking ligation clips for ligation of vessels and tissue bundles ranging in size from 5¿13 mm in diameter.It was alleged that the instrument was initially working during the case and the customer was able to apply clips.However, midway through the procedure, it was observed that the instrument stopped working, due to a loose grip cable.Failure analysis of the instrument identified a broken grip cable which is a failure mode that is known to impact clip application effectiveness.Deficiencies in clip application may lead to inadequate hemostasis.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 cholecystectomy procedure, the large clip applier had a broken cable.The procedure was completed and there was no patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the reporter confirmed that the clip applier was working fine initially and halfway through the procedure, they observed that it had a loose cable.That is when they replaced it with another instrument of the same kind to complete the procedure.The instrument was reportedly inspected prior to use, no collision occurred intra-operatively, and no instrument fragment fell inside the patient.No patient injury was observed.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: LARGE HEM-O-LOK CLIP APPLIER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10660140
• Report Number: 2955842-2020-11066
• Device Sequence Number: 3564439
• Product Code: NAY
• UDI-Device Identifier: 00886874111680
• UDI-Public: (01)00886874111680(10)N10190125
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2020

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: 420230-10
• Device Catalogue Number: 420230
• Device Lot Number: N10190125 977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/11/2020
• 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
• Patient Age: 18 YR
• Patient Weight: 114