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

Model Number 471405-06

Device Problem Defective Device (2588)

Patient Problem Muscle/Tendon Damage (4532)

Event Type  Injury  

Manufacturer Narrative

Isi has requested for the force bipolar instrument to be returned for failure analysis evaluation; however, the instrument has not yet been received.Therefore, the root cause of the customer reported failure has not been determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.Unable to perform system or instrument logs review with the lack of procedure information on file at the time.No image or video clip for the reported event was submitted for review.No additional technical review was required based on the complaint.This complaint is reportable due to the following conclusion: during a da vinci-assisted incisional hernia etep surgical procedure, the force bipolar instrument could not be unclamped while grasping mesh.The hinge of the force bipolar instrument was also dislodged and the surgeon was unable to remove the instrument through the cannula.When the instrument allegedly broke, bleeding occurred and an unspecified muscle was torn.The surgeon eventually used the port clutch to remove the instrument and cannula together.It is unknown how the muscle was torn.It is also unknown what medical intervention, if any, was performed as a result of the bleeding and the torn muscle.At this time, the cause of the customer reported failure mode is unknown.

Event Description

It was reported that during a da vinci-assisted incisional hernia etep surgical procedure, the customer was unable to remove the force bipolar instrument.The customer stated they had tried to initially use the instrument release key (irk) prior to calling intuitive surgical, inc.(isi) for assistance but was unsuccessful.The customer used the irk again and the instrument was released successfully.The customer stated that the hinge broken on the jaw.The customer also indicated that this issue has been reoccurring over the last three times they performed this procedure.(this record is for the second event).The customer continued with the case.Isi followed up with the robotics coordinator and obtained the following additional information: the robotics coordinator could not provide previous date information and specific information regarding each incident but informed that the issue occurred during etep procedures.The hinge of the force bipolar instrument allegedly ¿broke,¿ and the surgeon was unable to remove the instrument.The robotics coordinator indicated that the jaws were not stuck on tissue but on mesh.There was no unexpected tissue removal.The robotics coordinator stated there was bleeding of less than 750 ml when the instrument tore muscle.Further information about the torn muscle and what medical intervention was performed for the injury was not provided.The surgeon eventually removed the cannula by using the port clutch.It is unknown if the cannula incision line was enlarged to remove the instrument.The procedure was completed robotically.The robotics coordinator is not sure whether the instrument is available to isi for evaluation.Patient demographic information was requested but not provided.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• 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: 14065025
• MDR Text Key: 294123540
• Report Number: 2955842-2022-10963
• Device Sequence Number: 1
• Product Code: NAY
• 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,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2022
• 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: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• 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