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

Model Number 471405-06

Device Problems Difficult to Remove (1528); No Apparent Adverse Event (3189)

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

Event Date 05/25/2023

Event Type  Injury  

Manufacturer Narrative

Based on the claim against the product by the customer noting the tip of the 8mm force bipolar instrument slipped out of the shaft and broke, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the 8mm force bipolar instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint.Failure analysis found the primary finding of broken main tube to be related to the customer reported complaint.The instrument was found to have the main tube broken.The distal end was completely detached from the main tube and was returned with the instrument.Common causes of the failure mode broken instrument main tube are typically attributed to mishandling/misuse of the device.Damage during use may result from an accidental drop of the instrument or inadvertent collisions with other instruments.Excessive side loading on the instrument can also cause the main tube wall to collapse inwards leading to cracking and subsequent breakage.The complaint was confirmed based on failure analysis, which indicated that the device did contribute to the customer reported issue.Additional observation related to customer reported complaint: the instrument was found to have a grip cable dislodged at the proximal end.The instrument was also found to have a pitch cable dislodged in the housing at the proximal end.The instrument housing was removed and found that the pitch cable was dislodged.The root causes of dislodged pitch cable and grip cable at the proximal end are attributed to component failure.The probable root cause of a broken/cracked main tube is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments.Excessive side loading on the instrument can also cause the main tube wall to collapse inwards leading to cracking and subsequent breakage.This issue can be resolved by using an alternate instrument to complete the procedure.

Event Description

It was reported that during a da vinci-assisted inguinal hernia bilateral surgical procedure, the endoscope brushed against the 8mm force bipolar instrument in the patient and the tip of the instrument slipped out of the shaft and broke.The entire trocar had to be changed out of the patient along with a new instrument because they were unable to get it out of the trocar without breaking it.The procedure was completed with no reported patient injury.The initial reporter stated that the surgeon was performing an inguinal hernia repair when the issue occurred, the tip of the instrument would not straighten and was offset with the shaft, the instrument was inspected prior to use, the instrument brushed against the camera, they are unsure if the instrument was in strong grip mode at the time of the event.After use, it was misaligned with the shaft, no fragment fell into the patient¿s anatomy, and they were not able to provide patient information.

• 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: 17200910
• MDR Text Key: 317855792
• Report Number: 2955842-2023-16613
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K13230212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K214095
• 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
• Report Date: 05/31/2023

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: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: K13230212 0058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2023
• 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