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

Model Number 420172-16

Device Problems Break (1069); Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.The customer reported issue of damaged input disk was not confirmed during investigation.No input disk damage was observed at the chassis.The manual input of the disk knobs exhibited intuitive motion at the wrist.As part of investigation, the instrument was inspected and further investigated and found additional observations.Visual inspection found a dislodged flush tube and damage on the conductor wire insulation.Material of the conductor wire insulation measuring approximately 0.04" x 0.03" appeared to be missing, exposing the bare wire.Further inspection found thermal damage at the bipolar yaw pulley.Black char marks were present at the distal end.Any material missing from the damage of the yaw pulley is likely thermally induced.The known common causes of these failures are attributed to instrument mishandling and misuse.The instrument was subjected to electrical continuity and passed testing.Site history review: a review of the site's complaint history does not show any additional complaints related to this product and/or this event.No procedure video or image was submitted to isi for review.System log investigation: a review of the instrument log for the maryland bipolar forceps instrument lot# n12200302 / sequence 0014 associated with this event has been performed.Per logs, the instrument was last used for a procedure on (b)(6) 2020 using system sk2284.The alleged event occurred on the 6th use of the instrument.The instrument has 4 remaining usable lives with no subsequent use recorded.This complaint is being reported based on the following conclusion: the maryland bipolar forceps instruments are multiple-use electrosurgical endoscopic instruments with a grasping tip to be used in conjunction with the da vinci system and an external electrosurgical unit (esu).The instrument is designed to provide energy from the designated location on the instrument (the tip) to the planned anatomical location when used as intended.The energy is activated by pressing the designated pedal on the surgeon side console (ssc).Failure analysis of the maryland bipolar forceps instrument found conductor wire insulation damage with a passed electrical continuity test and thermal damage at the bipolar yaw pulley that was likely thermally induced.Although there was no arcing reported or seen through analysis, and there was no patient injury reported, if this failure were to recur, it could cause or contribute to an adverse event.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.Device expiration date was left blank as this instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system.The instrument has 4 remaining usable lives, therefore, had not expired.Implant date is blank because the product is not implantable.Information for the initial reporter is not available.Recall is not applicable.

Event Description

It was reported that during central processing, the maryland bipolar forceps instrument input disk was found to be damaged.There was no report of patient involvement.There was no report of unintended energy discharge or arcing, and no known instrument collision during the last instrument usage.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: MARYLAND BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10841448
• MDR Text Key: 216301022
• Report Number: 2955842-2020-11202
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112281
• UDI-Public: (01)00886874112281(10)N12200302
• Combination Product (y/n): N
• PMA/PMN Number: K050369
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420172-16
• Device Catalogue Number: 420172
• Device Lot Number: N12200302 0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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