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

Model Number 471205-17

Device Problem Material Fragmentation (1261)

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

Event Date 11/05/2021

Event Type  malfunction  

Event Description

It was reported that the fenestrated bipolar forceps instrument had a broken cable at the bending joint near the tip of robotic arm. There was no report of patient injury. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: the reporter is not sure when the issue occurred. There is no way for them to check for thermal damage and the person who reported the issue didn¿t state any errors from the xi robot stating any thermal damage. The only issue reported was regarding the wire. There was no injury to the patient reported. Information regarding patient demographics, relevant testing, and medical history was requested, however the reporter was not able to provide that information.

Manufacturer Narrative

The fenestrated bipolar forceps instrument has been returned and evaluated by the failure analysis team. Failure analysis investigations replicated/confirmed the customer reported complaint. Failure analysis found the primary failure of damaged conductor wire insulation to be related to the customer complaint. For clarification, the instrument was found to have damage to the conductor wire¿s insulation. The insulation exhibited thermal damage. No pieces were missing. The conductor wire was exposed, however no wires were damaged. Electrical continuity test was performed and the instrument passed. The root cause of the damaged conductor wire insulation was attributed to mishandling/misuse, commonly caused by collision with another energized instrument. Additional observations not reported by the site was that the instrument was found to have various scratch marks with light material removed on the main tube. The scratch marks were 0. 041¿- 0. 223* in length and were not aligned with the tube axis. The root cause of scratch marks /abrasions to the instrument main tube is typically attributed to mishandling/misuse. A review of the site's complaint history does not reveal any related complaints involving this product or this event. No image or procedure video was provided for review. A review of the instrument log for the fenestrated bipolar forceps instrument (471205-17/(b)(4)) associated with this event has been performed. Per the logs, the instrument was last used on (b)(6) 2021. This complaint is being reported based on the following conclusion: the instrument had conductor wire damage with no evidence of user mishandling or misuse. Thermal damage at or near a conductor wire breakage is evidence of 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: follow-up was attempted, but the missing patient information 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: 13091259
• MDR Text Key: 290183866
• Report Number: 2955842-2021-11819
• Device Sequence Number: 1
• Product Code: NAY
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 471205-17
• Device Catalogue Number: 471205
• Device Lot Number: N10210419 0226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2021
• 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 Treatment Data

Date Received: 12/27/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES.