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

Model Number 471205-17

Device Problem Material Fragmentation (1261)

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

Event Date 03/28/2022

Event Type  malfunction  

Manufacturer Narrative

The fenestrated bipolar forceps instrument has been returned for evaluation and the failure analysis investigation has been completed.The instrument was found with damaged insulation to the conductor wire near the distal idler pulley.Material appeared to be lifted off, but no material appeared to be missing.Bare wire was exposed and the electrical continuity test passed.No thermal damage was observed.The root cause of this issue is attributed to a component failure.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or procedure video was provided for review.A review of the instrument log for the fenestrated bipolar forceps instrument (471205-17/n10210322 0130) associated with this event has been performed.Per the logs, the instrument was last used in a procedure on (b)(6) 2022.It is unknown if the damage to the instrument occurred central processing, or during the last known procedural usage.This complaint is being reported based on the following conclusion: it was alleged that the instrument had conductor wire damage during a procedure.The frayed/broken conductor wire has 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 central processing and cleaning, the fenestrated bipolar forceps instrument's black cable was found to be frayed.There was no report of patient harm, adverse outcome or injury from the instrument's last procedural use.Multiple follow-up attempts to obtain additional information were completed.However, no further details have been received as of the date of this report.

• 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: 14233134
• MDR Text Key: 299389668
• Report Number: 2955842-2022-11281
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)N10210322
• 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,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: N10210322 0130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/18/2021
• 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