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	05/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
12- isi received the small grasping retractor instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the customer reported complaint.The instrument was found to have a broken pitch cable at the distal end.The broken cable segment that contains the crimp was still installed in the clevis.A log review was performed for the small grasping retractor instrument reported in this complaint (pn: (b)(4)) and the following was found: the instrument was last used on (b)(6) 2020.The instrument was on the 3rd life/usage of 10 for this procedure and not used for any following procedures.No error would appear for a broken instrument cable issue.A site review was conducted and no other complaints have been reported for this product.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.The customer reported complaint does not itself constitute an mdr reportable event and there was no reported patient injury.However, the broken pitch cable found during failure analysis could cause or contribute to an adverse event if the failure mode were to recur.Blank mdr fields: follow-up was attempted, but the patient information inwas unavailable.The expiration date for is not applicable.Field is not applicable because the product is not implantable.The information for fields in is not available.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer stated that the small grasping retractor instrument cable was defective.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: a backup instrument was used to complete the procedure.The procedure was delayed for a few minutes due to the instrument's exchange.

• 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: 10303299
• Report Number: 2955842-2020-10670
• Device Sequence Number: 470758
• 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,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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 554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1