MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FENESTRATED BIPOLAR FORCEPS

Model Number 471205-17

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested that the fenestrated bipolar forceps instrument be returned for failure analysis to be performed, but the instrument has not yet been received.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.A review of the site's complaint history does not show any additional complaints related to this product or this event.A review of the instrument log for the fenestrated bipolar forceps instrument (pn 471205-17/ lot # n12210524 0194) associated with this event was performed.Per logs, the instrument was last used on (b)(6) 2021 on system (b)(4).The instrument had 11 uses remaining after last use.Review of the provided image is consistent with the report of damaged conductor wire insulation.Root cause of the failure mode cannot be confirmed without the returned device.Based on the information provided at this time, this complaint is being reported due to the following conclusion: it was alleged that the instrument had conductor wire damage, with no evidence or claim of user mishandling or misuse.The damaged conductor wire has potential for electrical discharge at a location other than intended.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.

Event Description

It was reported that during central processing, the high frequency (hf) cable insulation for the deflection pulley at the distal end of the fenestrated bipolar forceps instrument was defective.There was no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: there were no signs of thermal damage and no loss of cautery.The instrument did not collide with any other instrument or tool during the last procedure.There was no delay in the procedure.It is unknown if the instrument was inspected prior to use.A replacement instrument was not used during the procedure.It is unknown if the instrument was inspected for damage after completion of the procedure.The damage was noticed during manual pre-cleaning in central processing.No patient information was provided due to data protection laws.

Manufacturer Narrative

D02- intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the reported complaint.The instrument was found to have insulation damage on the conductor wire, exposing the internal wires.The damage was located at the distal end on the bipolar yaw pulley.No material was missing and no thermal damage was observed.Electrical continuity was tested and passed.The root cause was attributed to a component failure.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• 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: 12978201
• MDR Text Key: 286913517
• Report Number: 2955842-2021-11714
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)N12210524
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471205-17
• Device Catalogue Number: 471205
• Device Lot Number: N12210524 0194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES