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

Model Number	470298-14
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The stapler 45 instrument has been returned and evaluated by the failure analysis team.The failure analysis investigations confirmed the customer reported complaint based on log review.However, failure analysis could not replicate the alleged failure during in-house testing.When the stapler 45 instrument was placed and driven on an in-house system, the instrument passed initialization, moved intuitively with full range of motion in all directions, and the jaws opened and closed properly.During testing a green 45 reload was used and the instrument clamped fired and unclamped successfully.Visual inspection was performed and no damage was observed.
Event or Problem Description
It was reported that during a da vinci assisted low anterior resection procedure, the stapler 45 instrument failed to unclamp.The procedure was completed without reported injury.Isi followed up with the initial reporter and on 1/20/2022, obtained the following additional information: the stapler release kit was used to open the jaws of the stapler.There was no harm to the patient.The procedure continued as planned.

• 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: 17093855
• Report Number: 2955842-2023-16101
• Device Sequence Number: 1932317
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T10200813
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

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: T10200813 0087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2020
• 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