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

Model Number 470172-16

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint "the wires at the front of the tip have damage (abrasions)." failure analysis found the primary failure of insulation damage on the conductor wire to be related to the customer reported complaint.The insulation damage was located at the distal end on the bipolar yaw pulley.No material was found to be missing.Electrical continuity was tested and passed.Root cause of insulation damage is attributed to a component failure.Failure analysis found the secondary failure of mechanical damage on the bipolar yaw pulley to be related to the customer reported complaint.The instrument was found to have mechanical damage on the bipolar yaw pulley.The location was relative to the conductor wire insulation damage.No material was found missing.Root cause is not established.A review of the instrument log for the maryland bipolar forceps (part # 470172-16 / lot # n12191216 0265) associated with this event has been performed.Per logs, the maryland bipolar forceps was last used on (b)(6) 2020 on system (b)(4), with 2 uses remaining.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.Based on the information provided at this time, this complaint is being reported because a bipolar instrument with damaged conductor wire insulation could lead to inadvertent transmission to tissue other than intended via the exposed conductor wire.While there was no harm or injury to the patient, the reported failure mode identified through failure analysis could likely cause or contribute to an adverse event if it were to recur.While there was no patient harm or injury, the reported failure mode could potentially cause or contribute to an adverse event if it were to recur.

Event Description

It was reported that after a da vinci-assisted partial nephrectomy surgical procedure, the maryland bipolar forceps instrument was found to have wire damage.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 11214370
• MDR Text Key: 257370498
• Report Number: 2955842-2021-10074
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112281
• UDI-Public: (01)00886874112281(10)N12191216
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470172-16
• Device Catalogue Number: 470172
• Device Lot Number: N12191216 0265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2019
• 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
• Patient Age: 48 YR
• Patient Weight: 105