MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; 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	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
12 - 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 small 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.As a result of the breakage, the instrument motion may have been non-intuitive.A review of system logs showed that the small grasping retractor instrument was last used on system# sh1279 on (b)(6)2020 and had 6 lives remaining.A review of complaints from the site was performed, and no complaints related to the product were found.Based on the information provided at this time, this complaint is being reported because small 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 into the patient.Although no patient harm was reported, if the issue were to recur, it could cause or contribute to an adverse event.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, or not provided.The expiration date is not applicable.Field is not applicable because the product is not implantable.Field is unknown.
Event or Problem Description
It was reported that during a da vinci assisted procedure, engagement of the small grasping retractor instrument was defective and the customer was unable to control the instrument's movement.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 stated that there was no patient involvement.

• Brand Name: ENDOWRIST
• Common Device Name: SMALL GRASPING RETRACTOR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10286263
• Report Number: 2955842-2020-10651
• Device Sequence Number: 16788456
• Product Code: NAY
• UDI-Device Identifier: 00886874111802
• UDI-Public: (01)00886874111802(10)N10190227
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/22/2020

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: N10190227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1