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

Model Number 471205-17

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Insufficient Information (4580)

Event Date 01/17/2024

Event Type  malfunction  

Event Description

It was reported that during central processing, the fenestrated bipolar forceps instrument had scorching damage to the gray plastic at the exit of the clamp or window as well as chipped wires.There was no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer stated the damage was identified after reprocessing.She was unsure if the instrument was inspected prior to reprocessing, when the damage occurred and if the instrument was inspected prior to the procedure.The customer reported that it was possible that the instrument collided with another instrument.No arcing was observed.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the fenestrated bipolar forceps instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument to perform failure analysis.The fenestrated bipolar forceps instrument was analyzed and found to have charring and/or localized melting on the outer surface of one bipolar yaw pulley at the base of the grip.As a result of the damage, a section of the active electrode (grip) is exposed that would not normally be exposed.The instrument passed the electrical continuity test.The complaint was confirmed by failure analysis.A review of the procedure logs indicated that a monopolar instrument was used during this case.The customer also reported a complaint of "chipped wires".This reported issue with the instrument could not be replicated nor confirmed.Upon visual and microscopic inspection, no cable damage or conductor wire damage was observed.No loss of conductor wire insulation was also observed.

• 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: 18680970
• MDR Text Key: 335044764
• Report Number: 2955842-2024-11114
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K214095
• 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,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• 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: K11230615 0301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2023
• 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