MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 45

Model Number	470298-14
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted urology surgical procedure, the stapler 45 did not fire.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the procedure was completed as planned with no report of patient injury.The issue was resolved by using another device.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the stapler 45 instrument involved with this complaint and completed the device evaluation.Failure analysis investigations did not replicate nor confirm the customer reported complaint.The instrument was returned with a white reload in the jaw.The reload was removed and the instrument was tested in house.During in house testing instrument failed during initialization.The instrument was found to have an unclamp failure based on log review.Additional analysis was performed on the instrument by an advanced failure analysis engineer.Instrument failed to unclamp per logs, but unclamp failure was not replicated during in-house testing.Initialization failure that occurred during initial failure analysis was likely a result of using the stapler release kit (srk) to manually unclamp the instrument in-house.The srk use likely jammed the clamp mechanism, causing a jammed mechanism homing failure.Instrument was unjammed in-house and the instrument passed initialization and was able to clamp, fire, and unclamp successfully with a plastic test sheet installed.However, when clamp performance was tested via a shim test, the instrument failed to clamp on the 0.032" shim in the pitch down position on multiple attempts.Clamping failed in the pitch down wrist orientation.Visual inspection of wrist components showed that the yaw plate was bent outwards towards the clamp cardan and the pivot pin was broken.Additionally, witness marks were observed on the clamp cardan shell that may be indicative of the cardan rubbing against other components during clamping/unclamping.Evidence suggests that the component damage at the wrist may be related to the unclamp failure.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 45
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 17015896
• Report Number: 2955842-2023-15015
• Device Sequence Number: 15342331
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T10200716
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

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: 470298-14
• Device Catalogue Number: 470298
• Device Lot Number: T10200716 0097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 05/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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
• Patient Sex: Unknown