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

Model Number 471172

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 03/27/2024

Event Type  malfunction  

Manufacturer Narrative

A return material authorization (rma) was not issued for return.Although the complaint was not confirmed by failure analysis since the product was not returned, the information gathered indicates that the device may have contributed to the customer reported issue.

Event Description

It was reported that towards the end of a da vinci-assisted total gastrotomy, one of the instruments was shot to the right almost as though the wire inside the instrument got pulled or cut or something.And the instrument was stuck, facing fully right and it broke the shaft of the instrument at the very top of the instrument itself so the customer couldn't straighten it.Per the initial reporter, it basically just cocked off to the side like an l and the customer straightened it as much as they could but couldn't get it out of the patient with the trocar so they had to cut it off at the top of the instrument with wire cutters in order to remove it from the patient.It was reported that it was possible that some pieces may have fallen into the patient, however, it was unknown at time of report.The procedure was a long case and was completed with no reported patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on and obtained the following additional information: via the isi clinical sales representative, the physician reported that the instrument was either a maryland bipolar forceps or a fenestrate bipolar forceps.The incident happened at the end of the procedure, just prior to undocking.The physician did not allege that the comment regarding the procedure being long was related to the da vinci system.There had been concern of fragments, but there were none and the patient was discharged and has not presented with any procedure related issues.The surgeon thought the event was a "freak accident".

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND BIPOLAR FORCEPS
• 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: 19178156
• MDR Text Key: 341620864
• Report Number: 2955842-2024-13843
• Device Sequence Number: 1
• Product Code: NAY
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471172
• Device Catalogue Number: 471172
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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