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

Model Number 470405-06

Device Problem Difficult to Remove (1528)

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

Event Date 09/23/2020

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted inguinal hernia repair procedure, the force bipolar instrument broke.An intuitive surgical, inc.(isi) clinical sales representative (csr) contacted technical support engineer (tse) from offsite to report the issue and said that an instrument broke and was stuck in the cannula.The tse advised the csr to try to use another instrument to remove it but the csr advised that the customer was unable to do so.The csr stated that the customer would need to make a bigger incision to remove the instrument.While on the support call, the csr got another call from the customer and had to go.The csr called back and stated that the customer was able to remove the instrument and cannula with larger incision.The csr stated that the customer installed a second force bipolar instrument and it broke as well.The customer removed the second force bipolar instrument and installed a prograsp forceps instrument to continue.The procedure completed and the patient is in recovery.Isi followed up with the initial reporter and obtained the following additional information regarding the reported event: during a da vinci-assisted inguinal hernia repair procedure, the force bipolar instrument broke.As the surgeon was reducing the hernia sack, a force bipolar instrument snapped and bent upon applying strong grip mode with the pedal.The distal tip of the instrument was ok but the proximal tip was partially bent but still on the instrument.There was no fragment fall into the patient.The customer ended up upsizing the incision port (arm 2, port 2, left arm) to remove the first force bipolar instrument.The customer reported having to do so because the broken tip of the instrument would not fit through cannula or the original incision and that's why they made a larger port incision; to remove the cannula and the instrument together.The same thing happened again when using a backup force bipolar instrument.As the surgeon was reducing the hernia sack, a second force bipolar instrument snapped and bent upon applying strong grip mode with the pedal.The distal tip of the instrument was ok but the proximal tip was partially bent but still on the instrument.There was no fragment fall into the patient.There was also no report of an enlarged/upsized port incision for the second occurrence.The instrument was removed without incident.The procedure completed as planned robotically with use of a backup prograsp forceps instrument and no patient harm or injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the force bipolar instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was confirmed: "broke while in patient, difficult to remove-intuitive rep called in." the instrument was found to have a severely bent grip.The grip was bent at the grip base where the grip tips meet the clevis pin.As a result, a cannula and seal came stuck and could not be removed from the main tube.This failure is most commonly caused by mishandling/misuse, such as excess force applied to the instrument jaws.

• 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: 17015994
• MDR Text Key: 316116614
• Report Number: 2955842-2023-15096
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10191104
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470405-06
• Device Catalogue Number: 470405
• Device Lot Number: N10191104 0213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 05/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2019
• 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