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

Model Number	420318-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the small grasping retractor involved with this complaint and completed the device evaluation.Failure analysis confirmed the reported complaint of a broken wire.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.A review of the instrument log for the small grasping retractor part# 420318-02/lot# m10120315 236 associated with this event has been performed.Per logs, the small grasping retractor was last used on (b)(6) 2020 on system (b)(4).A review of the site's complaint history does not show any additional complaints related to this product and/or this event.Based on the information provided at this time, this complaint is being reported because 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 into the patient.While there was no patient harm or injury, the reported failure mode could potentially cause or contribute to an adverse event if it were to recur.
Event or Problem Description
The customer conducted an inspection of the instruments and accessories in anticipation for a planned da vinci-assisted surgical procedure.During inspection, the customer found the small grasping retractor to have a broken wire at the tip.There was no patient involvement.Intuitive surgical, inc.(isi) followed up with the initial reporter to obtain additional information, but the customer was unable to provide any further details.

• 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: 10366180
• Report Number: 2955842-2020-10713
• Device Sequence Number: 3246772
• Product Code: NAY
• UDI-Device Identifier: 00886874111802
• UDI-Public: (01)00886874111802(10)M10120315
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Type of Report: Initial
• Report Date (Section B): 07/10/2020

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: 420318-02
• Device Catalogue Number: 420318
• Device Lot Number: M10120315 236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1