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

Model Number 471172-16

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 09/22/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) replicated and confirmed the customer reported complaint.The instrument was found to have thermal damage on the bipolar yaw pulley.The yaw pulley showed signs of charring and localized melting on the exterior base of the grip tips.The thermal damage to the yaw pulley is unrelated to the conductor wire.No insulation damage was observed.The conductor wire is not damaged or broken.An electrical continuity test was performed and passed.The root cause for this failure is attributed to user mishandling, commonly caused by collision with another energized instrument.No image or procedure video was provided for review.A review of the instrument log for the maryland bipolar forceps (471172-16/k10220105 0327) associated with this event has been performed.Per logs, the maryland bipolar forceps instrument was last used in a procedure on (b)(6) 2022 on system sk2104.The alleged instrument had one use remaining after the last procedural use.Based on the information provided at this time, this complaint is being reported due to the following conclusion: there was evidence of thermal damage to the yaw pulley.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.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is not applicable because the product is not implantable.Pma/510(k) number and adverse event are not applicable.

Event Description

It was reported that during central processing, the maryland bipolar forceps instrument was melted at the base of the tips.There was no report of patient involvement.Intuitive surgical, inc.(isi) performed follow up to obtain additional information, however, no further details have been received as of the date of this report.

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND 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: 15656378
• MDR Text Key: 302241920
• Report Number: 2955842-2022-14783
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)K10220105
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471172-16
• Device Catalogue Number: 471172
• Device Lot Number: K10220105 0327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2022
• 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.