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

Model Number	470545-03
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	03/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stapler 45 curved-tip instrument has been returned and evaluated by the failure analysis team.Failure analysis investigations did not replicate nor confirm the customer reported complaint "tip broke." the distal end of the instrument was not found to be broken.There was no loose, frayed or broken cables.There were no components broken or missing from the distal end.The instrument was installed on an in-house system.The instrument passed the initialization test.The instrument clamped and fired successfully.Additional findings not reported by site were that the instrument was found to have the yaw plate broken.Yaw plate web is bent outwards towards the clamp cardan.The root cause of broken instrument pivot plate is typically attributed to the misuse/mishandling, such as excess force applied to the distal end of the instrument.The instrument was found to have the upper chassis broken.A piece measuring approximately 0.326" x 0.469 was broken off.As a result the release lever and the spring became dislodged.The instrument was found to have the main chassis broken.A piece measuring approximately 0.109" x 0.265" was broken off.The instrument was found to have one of the housing snaps broken.The root cause of these failures are most commonly attributed to mishandling/misuse.Review of the dsp log found no errors related to the instrument.An isi field service engineer (fse) visited the site.During onsite visit, the fse inspected the system and found no fault.The fse also took a look at suspect stapler and saw no visible damage; however, could not inspect cartridge.The fse spoke with the customer who confirmed that other instrument were used on same arm with no issue; only the stapler gave them issues.Blank mdr fields: follow-up was attempted, but the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during a da vinci assisted pulmonary wedge resection procedure, a stapler 45 instrument broke inside of a patient.The site's robotic coordinator (roco) called in the issue to technical support after the procedure had been completed.The roco reported that they were able to retrieve all parts.The technical support engineer (tse) viewed system event logs for the reported procedure, but found no related entries.The roco stated they were able to complete the procedure.There was no reported patient injury.

• Brand Name: ENDOWRIST
• Common Device Name: CURVED TIP 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: 16928188
• Report Number: 2955842-2023-13607
• Device Sequence Number: 20522208
• Product Code: NAY
• UDI-Device Identifier: 00886874113806
• UDI-Public: (01)00886874113806(10)T10190204
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2021

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: 470545-03
• Device Catalogue Number: 470545
• Device Lot Number: T10190204 0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2019
• 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