MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MONOPOLAR CURVED SCISSORS

Model Number 430004-53

Device Problem Crack (1135)

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

Event Date 04/20/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted procedure, the end of the tip of a 6mm monopolar curved scissor instrument was damaged and the customer was unable to put the scissor tip on.The procedure was completed with no reported injury.Multiple attempts have been made to obtain additional information from the customer concerning the reported event with no success.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the monopolar curved scissors (mcs) involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed and replicated the reported issue.The mcs instrument was found to have the over molded seal adapter broken.The broken piece was not returned, measuring roughly 0.116¿ x 0.053¿ in size.The root cause of broken instrument other component (over molded seal adapter) is typically attributed to mishandling/misuse.An instrument review was performed and the following was confirmed: system sp0155, event date (b)(6) 2022 last used on that date with 13 uses remaining.This complaint is considered a reportable event due to the following conclusion: failure analysis identified that a fragment was missing from a portion of the device that enters the patient (distal end).Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of 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 SP
• Type of Device: MONOPOLAR CURVED SCISSORS
• 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: 14739825
• MDR Text Key: 303154316
• Report Number: 2955842-2022-12232
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874114285
• UDI-Public: (01)00886874114285(10)S10210722
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182371
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 430004-53
• Device Catalogue Number: 430004
• Device Lot Number: S10210722 0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2021
• 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