MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ASSY,MONOPOLAR CURVED SCISSORS,8MM,IS400

Model Number 470179

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 05/05/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, intuitive surgical, inc.(isi) became aware of maude report #11854911, which had the following event description: robotic curved scissor wrist instrument pulley snapped while scissor was in the patients abdomen.Area on instrument where pulley snapped was covered by a tip accessory cover.Isi was unable to determine site/account due to there being no contact/hospital information provided on the maude report.

Manufacturer Narrative

Based on the information currently provided, the cause of the reported failure remains unknown.If additional information is made available, a supplemental mdr will be submitted.This complaint is being reported due to the following conclusion: it was reported that during a da vinci-assisted surgical procedure, a monopolar curved scissors instrument¿s pulley snapped.While it was reported that the area on the instrument where the pulley snapped was covered by the tip cover accessory, it is unknown if the potential for fragments to have fallen was present.

• Brand Name: ASSY,MONOPOLAR CURVED SCISSORS,8MM,IS400
• Type of Device: MONOPOLAR CURVED SCISSORS
• 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: 14861043
• MDR Text Key: 303233165
• Report Number: 2955842-2022-12568
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 11/10/2021

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: 470179
• Device Catalogue Number: 470179
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 06/29/2022
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES