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

Model Number 471205-17

Device Problem Failure to Deliver Energy (1211)

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

Event Date 02/24/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps associated with this complaint and completed its investigation.Failure analysis (fa) confirmed the reported issue as the instrument was found to have a broken conductor wire at the proximal end.The location of the break is near the main tube/roll gear junction and the instrument failed the electrical continuity test.No signs of thermal damage were observed.Fa noted the root cause of this failure is attributed to a manufacturing issue.A review of the logs was performed.Per the review, the following was confirmed: system serial - sk3301, event date - (b)(6) 2022, and procedure name - radical prostatectomy without lymphadenectomy.The fenestrated bipolar forceps had 11 uses remaining out of a maximum of 14 total uses.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video clip was provided for review.This complaint is considered a reportable event due to the following conclusion: the instrument had conductor wire damage.The damaged/broken conductor wire has potential for electrical discharge 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.Blank mdr fields: device expiration date was left blank.Implant date is blank because the product is not implantable.Pma/510(k) number and adverse event are not applicable.

Event Description

It was reported that during a da vinci-assisted prostatectomy procedure, the fenestrated bipolar forceps instrument would not cauterize.The procedure was completed as planned with no reported injury.Follow-up was performed and additional information was obtained.According to the customer, after trouble shooting the inability to cauterize, it was determined the instrument was at fault and it was removed from service.This happened at the beginning of the surgical procedure, so the instrument was simply replaced.There was no visual damage to the instrument and no reported collisions.Instruments are thoroughly inspected during the cleaning and sterilization process and visually inspected and tested for movement in the or before use.The customer also noted that there was no injury, bleeding, damage or patient harm, so no testing or follow up was needed and no contributing history or physical information is applicable to the situation.

• 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: 14251933
• MDR Text Key: 290450860
• Report Number: 2955842-2022-11330
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)N10210322
• 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: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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: N10210322 0107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 117 KG