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

Model Number 420172-18

Device Problems Break (1069); Difficult to Remove (1528); No Apparent Adverse Event (3189)

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

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the claim against the product by the customer noting the maryland bipolar forceps (mbf) instrument could not be removed due to the bent tips, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the mbf instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint.The instrument was found to have the main tube broken.A piece measuring proximately 0.185¿ x 0.147¿ was not returned with the instrument.Common causes of the failure mode broken instrument main tube are typically attributed to mishandling/misuse of the device.The complaint regarding the broken main tube was confirmed by failure analysis, which indicated that the device did contribute to the customer reported issue.An additional observation not reported by the site was also observed.The instrument was found to have dried residue on the clamping pulleys.

Event Description

It was reported that during a da vinci-assisted pulmonary segmentectomy surgical procedure, the maryland bipolar forceps (mbf) instrument could not be removed due to the bent tips.The customer removed the mbf with the cannula.When the mbf and the cannula were outside the patient¿s body, the customer found that a part of the mbf was dislocated.The customer removed the dislocated part from the instrument to remove it from the cannula.Using a backup instrument, the procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no issue.The wrist of the mbf instrument could not be straightened due to physical damage to the instrument.Port incision was not increased to remove the instrument.There was no fragment falling into the patient¿s anatomy.There was no collision.The procedure was delayed about 10 minutes.

• Brand Name: ENDOWRIST;DAVINCI SI
• 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: 17149272
• MDR Text Key: 317965077
• Report Number: 2955842-2023-16429
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111475
• UDI-Public: (01)00886874111475(10)K10220731
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/19/2023

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: 420172-18
• Device Catalogue Number: 420172
• Device Lot Number: K10220731 258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2022
• 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