MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; VESSEL SEALER EXTEND

Model Number 480422-01

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/25/2022

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted prostatectomy surgical procedure, the customer had issues with the blade of the vessel sealer extend (vse) missing.The instrument was reportedly removed from the patient, and the blade was found to be missing at that time.It was suspected to be inside the patient's anatomy.An x-ray was performed but the blade was not found in the patient.No additional tests had been performed.Follow-up was performed with the customer, and additional information was obtained.The vse lot number was confirmed to be l91210919-0109.The customer used an x-ray to confirm that the metal fragment was not found inside the patient.No fragment was retrieved from the patient.There was no bleeding and no post-operative complications with the patient have been reported.There was no unusual damage noted on the instrument prior to the procedure.No instrument collisions were noted during the procedure.There was no wrist issue identified with the instrument.No further details were available.

Manufacturer Narrative

The product has not been returned for evaluation, although it has been requested.Therefore, failure analysis of the product related to the complaint cannot be performed.A follow-up mdr will be submitted if the product is returned and evaluated and/or if additional information is obtained.System log review confirmed that the vessel sealer extend was last used on (b)(6) 2022 with 0 uses remaining on system (b)(4).No image or procedure video was provided for review.This complaint is considered a reportable event due to the following conclusion: it was alleged that the vse instrument broke and a fragment potentially fell inside the patient during a da vinci assisted procedure.The missing fragment was realized as the instrument was being removed from the patient.An x-ray was performed, and no fragment was identified.At this time, the location of the missing instrument fragment remains unknown.In addition, it is unknown what caused the breakage to occur.Blank mdr fields: device expiration date was left blank.Field is blank because the product is not implantable.Field is blank because it is unknown if the initial reporter submitted a report to the fda.Fields are not applicable.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis found the primary failure of an exposed blade.The vessel sealer extend instrument was found to have a dislodged blade based on review of the logs.However, visual inspection of the instrument showed that the blade was not exposed outside of the blade garage.No conductor wire damage or snake wrist damage was found.There was significant bio debris found at the instrument tip.For clarification, the blade was not missing and was located within the blade garage.The blade and knife cable were inspected and no damage was found.The instrument was installed onto an in-house system and passed initialization.The instrument moved intuitively with full range of motion in all directions and the grips opened and closed properly.A cut test was performed several times and passed every time without the blade getting jammed.The root cause for this failure is not determinable/applicable.Additional tests were performed.The instrument passed the ceramic dot, knife slot, jaw gap, and energy delivery test.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: VESSEL SEALER EXTEND
• 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: 14191398
• MDR Text Key: 294641988
• Report Number: 2955842-2022-11235
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)L91210919
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173337
• 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,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422-01
• Device Catalogue Number: 480422
• Device Lot Number: L91210919 0109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• Is the Device Single Use?: Yes
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 79 KG