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

Model Number 470205-17

Device Problems Thermal Decomposition of Device (1071); Arcing (2583)

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

Event Date 07/08/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted low anterior resection surgical procedure, the fenestrated bipolar forceps instrument had no energy.The customer replaced the fenestrated bipolar forceps instrument with a back-up instrument of the same kind and completed the procedure with no reported injury.Intuitive surgical, inc.(isi) performed follow-up and obtained the following additional information regarding the reported event: the instrument was reportedly inspected prior to use, and no issues were noted.Arcing was observed during the procedure.It was confirmed that there was no patient harm, injury or adverse outcome due to the reported incident.There were no photographic images of the device or a video recording of the procedure.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.Failure analysis found the primary failure of the broken conductor wire to be related to the customer reported complaint.The instrument was found to have a broken conductor wire at the yaw pulley.The conductor wire was broken inside the grip-crimp socket.The instrument passed the electrical continuity test.The instrument was placed on an in-house system, and the energy test was performed.Energy was successfully received and delivered to the instrument.The energy was not at the tips but inside the yaw pulley.Severe thermal damage was observed.The root cause of this failure is attributed to a component failure.A review of the procedure log confirmed the surgical procedure was performed on the reported event date.In addition, a review of the instrument log showed the fenestrated bipolar forceps instrument (part# 470205-17 / lot# k13210830-0045) was last used on (b)(6) 2022 during a procedure with system sk3192.The fenestrated bipolar forceps instrument had 2 uses remaining.This last usage of the device was before the reported event date.(note: on (b)(6) 2022, the instrument was connected to the system by the isi failure analysis team for testing.) no image or video clip for the reported event was submitted to isi for review.This complaint is being reported due to the following conclusion: it was alleged that the instrument arced.The allegation could be related to the 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.Blank mdr fields: follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is blank because the product is not implantable.Pma/510(k) number and adverse event are not applicable.

• 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: 15331629
• MDR Text Key: 299033466
• Report Number: 2955842-2022-13777
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112359
• UDI-Public: (01)00886874112359(11)210826(10)K13210830
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470205-17
• Device Catalogue Number: 470205
• Device Lot Number: K13210830 0045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2022
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2021
• 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.