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

Model Number	410370-03
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that during a da vinci-assisted surgical procedure.The sheath was damaged from removing the stapler.It was unknown, if any fragment fell inside the patient.The procedure was completed with no reported patient harm or injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the stapler sheath involved with this complaint.And completed the device evaluation.Failure analysis confirmed, the customer reported issue.Visual inspection revealed a large tear at the distal end of the sheath.Material, approximately 0.13 x 0.09 appeared to be missing.The damage led to the sheath material to stretch out further than normal.This type of failure is associated with mishandling/misuse.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER SHEATH
• 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: 16925175
• Report Number: 2955842-2023-13102
• Device Sequence Number: 20543235
• Product Code: NAY
• UDI-Device Identifier: 00886874111130
• UDI-Public: (01)00886874111130(10)M90190729
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2020

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: 410370-03
• Device Catalogue Number: 410370
• Device Lot Number: M90190729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2019
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian