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

Model Number 471172-17

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive the maryland bipolar forceps instrument to perform failure analysis (fa).Fa was able to confirm the reported complaint.The instrument was found to have a bent grip, causing side to side misalignment of the grips.There was a 0.0380¿ offset at the tips.This causes the tip not to come together.Additional observation not reported by site: the instrument was found to have an excessive amount of dried residue around the clamping pulley cable grooves.The instrument was found to have charring and/or localized melting on the outer surface of one bipolar yaw pulley, resulting in an exposed electrode.The instrument passed the electrical continuity test.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the tips of a maryland bipolar forceps instrument were not coming together.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer noted no thermal damage during procedure.There was no issue for arcing observed during the procedure.There was no patient injury or adverse event during or after the surgical procedure.No photographic images of the device(s) or a video recording of the procedure available for isi review.

• 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: 18707400
• MDR Text Key: 335403010
• Report Number: 2955842-2024-11149
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/29/2024

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: 471172-17
• Device Catalogue Number: 471172
• Device Lot Number: K13230601 0187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• 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.