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

Model Number 471405-06

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 03/29/2022

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted hiatal hernia surgical procedure, the harmonic jaw got stuck in the force bipolar instrument and upon removal, one jaw of the force bipolar broke off.All pieces were accounted for and removed from the patient.The procedure was completed with a backup same instrument and with no patient harm.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the fragments were removed by grabbing them with a laparoscopic grasper and pulling them through the cannula.All fragments were confirmed retrieved by holding the pieces together and comparing it to another force bipolar instrument.No additional procedure nor post-operative tests was performed to confirm that all fragments were removed.The instrument was used for an hour or two during the case and it was inspected prior to use with no damage found.The surgeon was dissecting when the issue occurred and there were no functionality issues with the instruments prior to the incident.The instruments collided and were intertwined (harmonic tip inside fenestration of the force bipolar) and when pulled apart, it caused breakage.The force bipolar instrument was removed during the procedure and the wrist was straightened prior to removal with no resistance felt through the cannula and no other damage to instruments or cannula.There was no patient injury and the patient did not return to hospital due to the retained foreign object.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the force bipolar instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the reported complaint.Failure analysis found the primary failure of broken modular insulator to be related to the customer reported complaint.The instrument was found to have a broken modular insulator of the grip tips.A broken piece approximately 0.054" x 0.277" in size was not returned with the instrument.The root cause of this failure is attributed to manufacturing.Additional observation reported by site that is related to the primary failure was that the instrument was found to have a broken grip tip as a result of the broken modular insulator failure.A piece approximately 0.185" x 0.647¿ was found to be broken off.The broken piece was returned.The root cause of this issue is typically attributed to mishandling, such as excess force applied to the instrument jaws.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 procedure video was provided for review.A review of the instrument logs for the force bipolar instrument (part# 471405-06 / sn: (b)(4) / sequence # 0038) associated with this event was performed.The instrument was last used on (b)(6) 2022 on system serial# (b)(4) with 6 uses remaining.This complaint is being reported based on the following conclusion: it was alleged that the force bipolar instrument broke and a fragment fell inside the patient during a da vinci assisted procedure.The fragment was deemed accounted for during the same procedure with no patient injury.Failure analysis confirmed the instrument breakage that resulted in a fragment fall inside the patient was attributed to a manufacturing failure.

• Brand Name: ENDOWRIST
• Type of Device: FORCE BIPOLAR
• 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: 14252049
• MDR Text Key: 290399571
• Report Number: 2955842-2022-11332
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K12211018
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180351
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: K12211018 0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• 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