MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. HOT SHEARS (MONOPOLAR CURVED SCISSORS); SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Model Number 400180

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2017

Event Type  malfunction  

Event Description

During a robotic case, staff noticed the tip cover accessory for monopolar curved scissors are splitting at the seam.Staff went through 5 tips during the one case.One of them is missing a very small piece that became detached during the procedure.This piece was likely removed from the surgical site via suction.Without complete coverage on the monopolar scissors, patients are at risk for burns.The patient was not harmed as the covers were replaced when defects were noted.The procedure was completed as planned.Clinical engineering received 4 of these tip covers, all from the same lot #.Microscope images were obtained and demonstrate that the origin of each split is at the seam of the material.All pieces will be returned to intuitive surgical for failure analysis.Per site reporter: an rma will be issued and the device will be returned for failure analysis.We will monitor the analysis via the customer portal.

• Brand Name: HOT SHEARS (MONOPOLAR CURVED SCISSORS)
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 7112175
• MDR Text Key: 94654536
• Report Number: 7112175
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111048
• UDI-Public: (01)00886874111048
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: 400180
• Device Lot Number: M10170912
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 123