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

Model Number	420230-07
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the large hem-o-lok clip applier instrument associated with this complaint and completed the device evaluation.Failure analysis was not able to confirm/reproduce the reported complaint.The instrument was placed and driven on an in-house system and passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.Additional observations not reported by the site and that were not related to the original customer-reported complaint: the clip test was performed and failed.Upon visual inspection, the instrument was found to have loose grip cables, likely causing the failed clip test.The housing was removed for inspection and damage was found.The root cause of this failure is attributed to a component failure.A review of the instrument log of the large hem-o-lok clip applier (part # 420230-07/ lot # n1014729-271) associated with this event has been performed.Per the logs, the instrument was last used on (b)(6) 2021 on system sh1417.The alleged event occurred on the 52nd use of the instrument.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: failure analysis found the large hem-o-lok clip applier instrument to have loose grip cables, likely causing the failed clip test.Deficiencies in clip application may lead to inadequate hemostasis.While there was no patient involvement, 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 surgical procedure, the large-hem-o-clip applier was observed to have a yellow flashing light and an error stated that the instrument was not inserted properly.A backup instrument of the same kind was used and the procedure was completed as planned with no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) made multiple attempts to gather additional information, but was not successful.No further details have been recieved as of the date of this report.

• 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
• MDR Report Key: 12186784
• Report Number: 2955842-2021-10812
• Device Sequence Number: 19672419
• Product Code: NAY
• UDI-Device Identifier: 00886874111680
• UDI-Public: (01)00886874111680(10)N10140729
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/23/2021

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: 420230-07
• Device Catalogue Number: 420230
• Device Lot Number: N10140729 271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 07/18/2021
• 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