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

Model Number 471205-17

Device Problem Arcing (2583)

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

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested that the fenestrated bipolar forceps instrument 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 has not be determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.A review of the site's complaint history does not reveal any related complaints involving this product or this event.A review of the instrument log for the fenestrated bipolar forceps instrument (part number: 471205-17, lot number: k10210531 0034) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2021 on system (b)(4).The instrument was used for 9 minutes.The instrument had 7 uses remaining out of 14 maximum tool uses.No image or procedure video was provided for review.This complaint is reported due to the following conclusion: it was alleged that the instrument arced 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.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.

Event Description

It was reported that during a da vinci-assisted paraesophageal hiatal hernia surgical procedure, the customer noted a spark at the jaws of the fenestrated bipolar forceps instrument while using bipolar energy.The customer removed the instrument and noted a crack on the yellow plastic insulation.The customer used a backup instrument.The site continued to complete the procedure as planned with no reported patient injury.Intuitive surgical (is) made multiple attempts to contact the reporter to obtain additional information about the complaint; however, attempts were not successful.

• 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: 13057235
• MDR Text Key: 286523122
• Report Number: 2955842-2021-11788
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)K10210531
• 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: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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: K10210531 0034
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• 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