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

Model Number 470172-16

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

The maryland bipolar forceps instrument has been returned and evaluated by the failure analysis (fa) team. Failure analysis investigations replicated and confirmed the customer reported complaint. Failure analysis found the primary failure of thermal damage to the bipolar yaw pulley to be related to the customer reported complaint. The instrument was found to have thermal damage on the bipolar yaw pulley. The instrument passed the electrical continuity test. Root cause of this failure is attributed to mishandling/misuse. Additional observation not reported by site was that related to the primary failure was that the instrument was found to have signs of thermal damage to the conductor wire¿s insulation at the distal end. The conductor wire was not exposed as a result. The damaged insulation is near the bipolar yaw pulley thermal damage failure. The root cause of this failure is attributed to mishandling/misuse. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. A review of the instrument log for the maryland bipolar forceps instrument (470172-16/n10180713 0060) associated with this event has been performed. Per the logs, the instrument was last used on (b)(6) 2022 in a radical prostatectomy with lymphadenectomy procedure. No image or procedure video was provided for review. This complaint is being reported based on the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage. Failure analysis performed evaluation and confirmed the thermal damage. It is unknown if the thermal damage occurred as a result of central processing, or if it occurred intraoperatively. While there was no reported harm or injury to a 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. 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 central processing, the maryland bipolar forceps instrument was burned and chipped. There was no report of patient involvement. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: the reporter confirmed the issue was noticed after the instrument had been reprocessed and during inspection. They did not note the damage prior to reprocessing. No further information was obtained.

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND 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: 14190938
• MDR Text Key: 289948292
• Report Number: 2955842-2022-11210
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 470172-16
• Device Catalogue Number: 470172
• Device Lot Number: N10180713 0060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2018
• 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: 04/22/2022 Patient Sequence Number: 1

Treatment

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