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

Model Number 420205-16

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

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

Event Date 11/08/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested that the fenestrated bipolar forceps 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 device logs for the fenestrated bipolar forceps (part# 420205-16 | lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the fenestrated bipolar forceps was last used on (b)(6) 2021 via system serial# (b)(4).There were 7 uses remaining after this last usage.A review of the site's complaint history does not show any additional complaints related to this product or this event.No photo or video was provided by the site for review.This complaint is being reported due to the following conclusion: the instrument arced and had thermal damage with no evidence or claim of user mishandling or misuse.The allegation could be related to the potential for electrical discharge at a location other than intended.At this time, it is unknown what caused the event to occur.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, i.E patient race, ethnicity, relevant tests, results, and patient medical history were not provided.The expiration date is not applicable.Implant date is blank because the product is not implantable.Information for the blank fields in name and address is not available.Fields pma/510(k) number and adverse event are not applicable.

Event Description

It was reported that during a da vinci-assisted liver resection surgical procedure, the fenestrated bipolar forceps instrument suddenly sparked.Then, the white plastic part was noted to be melted.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use and there was no damage or anything out of ordinary.Site used pin gauge and there was no problem.The arcing event occurred when the surgeon was cauterizing.Bipolar energy was activated when the arcing event occurred.Conmed generator was used.The instrument was in use for 30 minutes prior to the arcing event.Prograsp forceps and monopolar curved scissors were also being used when the event occurred.The instrument tips collide with other instrument during procedure.The instrument also arced when it did not contact the tissue.Sometimes instrument tip was touching to metal clips as well.The jaws were not immersed in liquid or contaminated by carbonized tissue (bio debris) prior to activating the instrument.The instrument was removed for cleaning and straightened prior to event.Surgeon has no idea about what caused the issue.The patient did not return to the hospital due to experiencing any post-surgical complications as a result of the arcing event.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps (fbf) instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint.Fa found the primary failure of bipolar yaw pulley thermal damage between the grips to be related to the customer reported complaint.The instrument was found to have charring and localized melting at the grip base between the grips.The instrument passed the electrical continuity test.No damage to the conductor wire was observed.The root cause of thermal damage between grips instrument bipolar yaw pulley is typically attributed to the user, most commonly caused by insulation degradation and carbonized tissue creating a conductive path.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• 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: 12942611
• MDR Text Key: 281826272
• Report Number: 2955842-2021-11674
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111642
• UDI-Public: (01)00886874111642(10)N10210719
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K050369
• 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: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420205-16
• Device Catalogue Number: 420205
• Device Lot Number: N10210719 219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• 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