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

Model Number	420278-06
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2020
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 grasping retractor 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.A site history was performed and no related complaints were found.A review of system logs showed that the grasping retractor instrument had 3 lives remaining.No image or video was provided for review.Based on the information provided at this time, this complaint is being reported because the grasping retractor 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 no patient harm occurred, if this malfunction were to recur it could potentially cause or contribute to an adverse event.Follow-up was attempted, but the patient information in section b was either unknown or unavailable.The expiration date is not applicable.The product is not implantable.
Event or Problem Description
It was reported that during a da vinci assisted abdominoperineal resection, the grasping retractor 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 site did not perform any tests but performed a visual inspection of the cavity for loose fragments.The reporter also confirmed the surgery as a combination of laparoscopic and robotic abdominoperineal resection, performed on (b)(6) 2020.

• Brand Name: ENDOWRIST
• Common Device Name: GRASPING RETRACTOR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10073396
• Report Number: 2955842-2020-10501
• Device Sequence Number: 2916132
• Product Code: NAY
• UDI-Device Identifier: 00886874111772
• UDI-Public: (01)00886874111772(10)N10150129
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 420278-06
• Device Catalogue Number: 420278
• Device Lot Number: N10150129 625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 51 YR
• Patient Weight: 126