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

Model Number	410370-03
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	10/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An advanced failure analysis engineer reviewed the pictures provided and found the stapler sheath had a rectangular piece detached from the distal end.No obvious damage was observed on the stapler instrument picture.Intuitive surgical, inc.(isi) received the disposable stapler sheath accessory associated with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint.Failure analysis found the primary failure of damaged sheath to be related to the customer reported complaint.Visual inspection of the sheath accessory found the distal tip to be physically damaged.There was a piece torn off measuring approximately 0.152" x 0.631" in length.The torn piece was returned with the accessory.This failure is typically associated with mishandling/misuse.
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection surgical procedure, when the stapler instrument was removed from the canula, the disposable stapler sheath accessory got damaged in 2 pieces.A backup accessory of the same type was used and the procedure was completed with no reported injury.The stapler sheath is a single-use disposable accessory intended to cover the stapler wrist and the lower shaft to prevent tissue from being drawn into the moving/rotating components of the instrument.An installation tool (packaged with the sheath) aids in installation, removal and repositioning of the sheath.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: the customer stated a fragment of the disposable stapler sheath accessory fell into the patient and was retrieved during the same procedure.The stapler cannula was inspected prior to use with a gauge pin with no problems found.The customer stated the stapler instrument wrist was not straight when the instrument was removed.Pictures of the stapler instrument and sheath involved with the complaint were provided.

• 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: 16925242
• Report Number: 2955842-2023-13159
• Device Sequence Number: 20563176
• Product Code: NAY
• UDI-Device Identifier: 00886874111130
• UDI-Public: (01)00886874111130(10)NA
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2021

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: 410370-03
• Device Catalogue Number: 410370
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2015
• 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 Sex: Unknown