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

Model Number	470298-14
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the stapler 45 instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed and replicated the reported event.The instrument was found to have a broken grip cable at grip housing.The broken grip cable and crimp would be retained by the stapler sheath.Root cause is attributed to a component failure.Failure analysis found the secondary failure of failed engagement to be related to the customer reported complaint.Based on log review and during in-house testing, the instrument was found to have multiple engagement failures, error code 22020.The engagement failures were likely caused by the broken grip cable.As a result, functional tests were unable to be performed.Additional observations not reported by site: visual inspection was performed and the instrument was found to have a broken cardan shell.As a result, the cardan shaft was dislodged.The dislodged clam cardan shaft was not returned.The instrument was found to have a broken pivot pin.The instrument's steering hypotube was found to be bent.The root cause of these failures are attributed to mishandling.The conductor wire was found to have damaged insulation.As a result, the internal wires are exposed.Electrical continuity was performed and passed.The root cause of this failure is attribute to a component failure.The instrument was found to have corrosion on the bearings.The root cause of this failure is attributed to mishandling.The instrument was found to have an initialization failure based on log review of remotefe.The instrument was found to have a clamp homing failure / failure with unclamp/unfire hardstop (in clamp/fire homing).
Event or Problem Description
The stapler 45 instrument was returned with no alleged complaint.No allegation was made against this product.The procedure was completed with no reported injury.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.

• 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: 17045894
• Report Number: 2955842-2023-15497
• Device Sequence Number: 8511063
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T10210218
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/08/2022

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: T10210218 0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2021
• 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