MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MONOPOLAR CAUTERY

Model Number	420142-04
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the monopolar cautery involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the reported issue.The instrument was found to have thermal damage to its grip tips and broken electrical contacts at the distal tip.The instrument failed the electrical continuity test.Functional testing of energy delivery could not be performed due to the thermal damage.While the root cause for this failure is typically attributed to the user, it is unknown what caused the damage for this event.Additional finding not related to the reported thermal damage: the instrument was found to have a dislodged flush tube inside the housing.Root cause of this failure is typically attributed to the user.A review of the instrument log for the monopolar cautery (part # 420142-04, lot # s10131218 983) associated with this event has been performed.The instrument was last used on (b)(6) 2020 on system (b)(4).The alleged event occurred on the 14th use.There is no indication that the instrument was used in subsequent procedures after the alleged event reported on this record.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: the monopolar cautery instrument tip was found melted and charred.Melting/charring is evidence of the deliverance of electrical current 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 or Problem Description
It was reported that during central processing, the monopolar cautery instrument tip was found melted and charred.It was removed from service and replaced.There was no reported injury.Intuitive surgical, inc.(isi) obtained the following information about the complaint: there was nothing abnormal at the visual inspection on the sterile field.No arcing was observed.The monopolar cord was not connected to a bipolar instrument.The customer used conmed system 5000 generator with settings: cut: 40, coag: 40, bip 35.The monopolar scissors were used during 90% of case with the maryland bipolar forceps.Often during the dissection, the tips were covered in carbonized tissue requiring being removed and cleaned.There was no patient harm and the surgery completed as planned.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: MONOPOLAR CAUTERY
• 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: 14332357
• Report Number: 2955842-2022-11474
• Device Sequence Number: 14736949
• Product Code: NAY
• UDI-Device Identifier: 00886874111406
• UDI-Public: (01)00886874111406(10)S10131218
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

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
• Operator of Device: Health Professional
• Device Model Number: 420142-04
• Device Catalogue Number: 420142
• Device Lot Number: S10131218 983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 05/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown