MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; REDUCER

Model Number	470381-12
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the metal tip was broken and fell off from 12-8mm reducer.The metal end was found in abdominal cavity incidentally.The procedure was completing as planned with no reported injury.
Additional Manufacturer Narrative
A return material authorization (rma) was issued to the customer requesting to have the intuitive surgical, inc.(isi) device returned.Additional information is being gathered to determine the contribution of the device to the customer reported issue.Image review: review of the provided image is consistent with the "metal end was found in abdominal cavity incidentally".The picture shows a metal ring detached.Root cause of the failure mode cannot be confirmed without the returned device.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the device was inspected prior to use and no damage was noted.The surgeon saw part of the reducer had fallen during installation.The reducer was in use for about two hours; there was no functionality issue noted.No collisions were observed during the procedure.The surgical staff did not feel any resistance upon removal of the reducer through the cannula.There was no damage to the cannula after the event occurred.There was no other damage to the instrument after the event.All fragments were retrieved.No additional surgical procedure was required to remove the fragment.There were no post-operative tests performed to check for remaining fragments.The customer completed the procedure robotically after replacing the reducer.The patient did not return to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.Additionally, isi did receive a da vinci product to perform failure analysis.The reducer was analyzed and found to be in a damaged condition.Upon visual inspection, it was noted that the breakage occurred near the tip of the reducer and the tip was found detached.No material was found to be missing.The broken section of the shaft was observed to be adhered to the detached tip.

• Brand Name: ENDOWRIST
• Common Device Name: REDUCER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20603992
• Report Number: 2955842-2024-21442
• Device Sequence Number: 7346351
• Product Code: NAY
• UDI-Device Identifier: 10886874112585
• UDI-Public: (01)10886874112585(10)L83231102
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K162411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470381-12
• Device Catalogue Number: 470381
• Device Lot Number: L83231102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Required Intervention
• Patient Sex: Prefer Not To Disclose