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

Model Number 471205-17

Device Problems Failure to Deliver Energy (1211); Material Split, Cut or Torn (4008)

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

Event Date 09/29/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical ventral hernia tapp procedure, a fenestrated bipolar forceps instrument was unable to produce energy when cord attached to both instrument and electrosurgical unit machine.Site replaced the bipolar energy cord and still no energy was produced through the instrument.The instrument was replaced.On (b)(6) 2021, intuitive surgical, inc.(isi) contacted the original reporter (hospital employee) and obtained the following information: they used a backup instrument.The procedure was completed robotically.There was no injury to the patient.On (b)(6) 2021, isi contacted the original reporter and obtained the following information: patient information was requested, but was not provided.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) was able to confirm/reproduce the reported complaint.The instrument was found to have a broken conductor wire at the distal end.The broken wire only looks attached due to its insulation and not completely broken.The instrument failed the electrical continuity test, however, the instrument would pass the electrical continuity test intermittently with certain articulation of the wrist.No signs of thermal damage were observed.Root cause of this failure is attributed to a component failure.Additional observation not reported by site that is related to the primary failure: the instrument was found to have damage to the conductor wire¿s insulation at the distal end.The conductor wire was exposed as a result.Root cause of this failure is attributed to a component failure.A review of the instrument log of the fenestrated bipolar forceps (part # 471205-17 / lot # n10210621-0241) associated with this event has been performed.Per the logs, the instrument was last used on (b)(6) 2021 on system (b)(4).The alleged event occurred on the 6th use of the instrument.A review of the site's complaint history does not show any additional complaints for this product.No image or procedure video was provided for review.Based on the information provided, this complaint is considered a reportable malfunction due to the following conclusion: failure analysis found damage to the conductor wire at the distal end.The conductor wire was not completely broken and the instrument would pass the electrical continuity test intermittently with certain articulation of the wrist.While there was no harm or injury to a patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur due to the potential of stray energy from the exposed wire.Blank mdr fields: follow-up was attempted, but the missing patient was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

• 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: 12977641
• MDR Text Key: 290156443
• Report Number: 2955842-2021-11713
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)N10210621
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• 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: N10210621 0241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2021
• 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.