MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; VESSEL SEALER EXTEND

Model Number	480422-01
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) requested the vessel sealer instrument involved with this complaint to be returned for failure analysis.However, as of the date of this report, the instrument has not been received.A review of the site's complaint history does not show any additional complaints related to this product.A review of the instrument log for the vessel sealer associated with this event has been performed.Per logs, the vessel sealer (940322-07/ m10190324-0043) was last used on (b)(6) 2020 on system sk2535.The alleged event occurred on the 1st use of the instrument.The instructions for use for the da vinci instruments includes the following: warning: to prevent damage to the instrument, always straighten the instrument wrist under endoscopic visualization before removing the instrument through the cannula.Based on the information provided at this time, this complaint is being classified as a reportable event due to the following conclusion: during the removal of the vessel sealer from the patient, the surgeon did not completely straighten the instrument wrist prior to removal, resulting in damage to the instrument.Fragments from the broken vessel sealer instrument fell inside the patient and only some of the fragments were retrieved.The procedure was completed with no further issues reported.At this time, the patient's current status, and whether the patient returned to the hospital due to complications related to retaining a foreign object are unknown.The product is not implantable.
Event or Problem Description
It was reported that during a da vinci-assisted gastric bypass surgical procedure, during the removal of the vessel sealer from the patient, the surgeon did not completely straighten the instrument wrist prior to removal, resulting in damage to the instrument.Fragments from the broken vessel sealer instrument fell inside the patient ,and only some of the fragments were retrieved.The procedure was completed with no other reported issues.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
Additional information was obtained that revealed the instrument involved in this event was a vessel sealer extend.Refer to the updated product information in section d.D11 - intuitive surgical, inc.(isi) has received the vessel sealer extend instrument involved with this complaint.The customer reported issue was replicated/confirmed.Failure analysis found the primary finding of grip tips broken to be related to the customer reported complaint.The vessel sealer extend instrument was found to have a broken grip tip overmold.A piece approximately 0.188" x 0.327" part was broken off and not returned with the instrument.No other damage was found and the review of the logs showed no failures.Root cause of this failure is attributed to mishandling/misuse.

• Brand Name: ENDOWRIST
• Common Device Name: VESSEL SEALER EXTEND
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10839726
• Report Number: 2955842-2020-11197
• Device Sequence Number: 4135318
• Product Code: NAY
• UDI-Device Identifier: 10886874112745
• UDI-Public: (01)10886874112745(10)M10190324
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K173337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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: 480422-01
• Device Catalogue Number: 480422
• Device Lot Number: L92200728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 01/31/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Outcome Attributed to Adverse Event: Other