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

Model Number 471205-17

Device Problem Difficult to Remove (1528)

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

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The fenestrated bipolar forceps (fbf) instrument was analyzed and found to have the main tube broken.Several fragments were found missing.The distal end was completely detached but it was returned with the instrument.Further investigation found dislodged grip cable at the proximal end and dislodged pitch cable in the housing.The instrument was also found to have dried residue around the clamping pulley cable groove.The complaint was confirmed by failure analysis.

Event Description

It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the fenestrated bipolar forceps (fbf) instrument became inoperative and could not be removed.The customer cut the fbf to remove it.The customer used a backup fbf instrument to continue with the planned procedure.No fragment fell inside the patient.No known impact or patient consequence was reported.Isi followed up with the initial reporter and obtained the following additional information: the instrument tip stopped moving.The tissue was not adhered to the instrument.No tissue was excised due to the event.There was no unexpected bleeding.The patient did not experience any post-operative complications.There was no fragment falling into the patient¿s anatomy.There was no patient impact.The procedure was not delayed.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED 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: 18700844
• MDR Text Key: 335301359
• Report Number: 2955842-2024-11412
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471205-17
• Device Catalogue Number: 471205
• Device Lot Number: K11230226 0182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• 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.