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

Model Number 471172-16

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Insufficient Information (4580)

Event Date 07/13/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the maryland 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 instrument is returned (post failure analysis evaluation) or if additional information is received.A review of the instrument log for the maryland bipolar forceps instrument (pn# 471172-16 lot# k10220323-0024) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2022 on system (b)(4) for approximately 2 hr 5 min.The alleged event occurred on the 4th use of the instrument with 10 uses remaining.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: it was alleged that during central processing, the maryland bipolar forceps instrument was found to have insulation burnt off.The damaged/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, the maryland bipolar forceps instrument was found to have insulation burnt off.There was no report of patient involvement.Intuitive surgical, inc.(isi) attempted to obtain additional information via follow-up.However, no further details have been received as of the date of this report.

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND 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: 15563129
• MDR Text Key: 301356616
• Report Number: 2955842-2022-14456
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)K10220323
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K131861
• 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
• Report Date: 09/08/2022

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: 471172-16
• Device Catalogue Number: 471172
• Device Lot Number: K10220323 0024
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• 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