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

Model Number 471205-17

Device Problems Thermal Decomposition of Device (1071); Smoking (1585); Sparking (2595)

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

Event Date 06/30/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted prostatectomy surgical procedure, the shaft of the fenestrated bipolar forceps (fbf) instrument was burnt when firing with the monopolar curved scissors (mcs).The issue occurred when the customer was attaching body fluid on the shaft.The customer used a backup instrument to continue.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on 07-july-2022: the fenestrated bipolar forceps instrument was visually inspected prior to use and no abnormality was found.The reporter reviewed the procedure video and found no adhesions on the shaft.The tip of the forceps was gripping the vas deferens when the issue occurred.The surgeon often use the two energy instruments together every time.Sparks and smoke were noted when the mcs was energized with the monopolar coagulation.It was unknown if the energy leaked from the mcs or fbf instrument.The arc grounded on the pulley cover of the fbf.A grounding pad was used on the patient's left leg.The grounding pad did not appear to have any issues or defects.The customer was using the erbe generator.It is unclear from the procedure video whether the tip of the mcs directly contacted the fbf.The instrument jaws were not immersed in liquid or contaminated by carbonized tissue (bio debris) prior to activating the instrument.There was no patient injury.It is currently unknown if the patient has returned to the hospital due to experiencing any post-surgical complications as a result of the arcing event.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation replicated/confirmed the customer reported complaint.Fa found the primary failure of the thermal damage to the yaw pulley to be related to the customer reported complaint.The fenestrated bipolar forceps instrument was found to exhibit thermal damage at the base of the grips on the yaw pulley.There was no damage to the conductor wire insulation.The instrument passed the electrical continuity test.The root cause is attributed to mishandling/misuse.Additional finding not reported by site was also identified: the fenestrated bipolar forceps instrument was found to have multiple input disks cracked.Hairline cracks were found on grip input disks.The root cause of the cracked instrument input disks is typically attributed to mishandling/misuse.No image or video clip for the reported event was available for review.A review of the instrument logs for the fenestrated bipolar forceps (part number 471205-17/ lot number k11211004-0101) associated with this event has been performed.Per this review of the logs, the fenestrated bipolar forceps instrument was last used in a procedure on (b)(6) 2022 on system (b)(4).There were 5 uses remaining after this last procedural use.Refer to the report under patient identifier (b)(6) for the fenestrated bipolar forceps that was used in the same procedure.This complaint is considered a reportable malfunction due to the following conclusion: it was alleged that the fenestrated bipolar forceps instrument exhibited signs indicative of thermal damage.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.

• 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: 15128546
• MDR Text Key: 296848142
• Report Number: 2955842-2022-13229
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)K11211004
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• 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: K11211004 0101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2021
• 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
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian