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

Model Number 471205-17

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 06/15/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the fenestrated bipolar forceps instrument involved in this case and failure analysis (fa) testing has been performed.Fa was able to confirm the reported complaint.The instrument was found to have thermal damage on the bipolar yaw pulley.The instrument passed the electrical continuity test.The instrument was placed on the in-house system and successfully received and delivered energy.No damage was found on conductor wire.Root cause of this failure is attributed to mishandling/misuse no image or video clip for the reported event was available for review.A review of the instrument logs showed the fenestrated bipolar forceps instrument (part# 471205-17 / lot# k12211213-0036) was last used on (b)(6) 2022 during a radical prostatectomy with lymphadenectomy procedure with system (b)(4).The fenestrated bipolar forceps instrument had 5 uses remaining.This last usage of the device was before the reported central processing event date.This complaint is being reported due to the following conclusion: it was alleged that the fenestrated bipolar forceps instrument exhibited signs indicative of thermal damage.At this time, 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 was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Field is blank because the product is not implantable.Information for the blank fields is not available.Fields are not applicable.

Event Description

It was reported that during central processing, the plastic at the tip of the fenestrated bipolar forceps was found burnt.There was no report of patient involvement.Intuitive surgical, inc.(isi) followed up with the nurse and obtained the following additional information: since this instrument was not used on june 14, it seems the instrument should be below that was used on (b)(6).The initial report was incorrect, the damage was noted during cleaning after the procedure.The thermal damage occurred during the last procedure.There was no anomaly observed at inspection prior to use.It was unknown if arcing was observed during last usage.There was no injury to the patient.

• 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: 15036915
• MDR Text Key: 296040861
• Report Number: 2955842-2022-13026
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)K12211213
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2022
• 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: K12211213 0036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2021
• 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