MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE TIP COVER ACCESSORY

Model Number 400180-14

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

Isi has requested the monopolar curved scissors (mcs) tip cover accessory to be returned for evaluation. However, as of the date of this report, isi has not received the product. Therefore, the root cause of the customer reported failure mode could not be determined. A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received. The customer reported complaint does not itself constitute an mdr reportable event; however, evidence of arcing found during failure analysis could cause or contribute to an adverse event if the malfunction were to recur.

Event Description

It was reported that after successfully completing a da vinci-assisted surgical procedure, the customer inspected the instruments and accessories and found a crack on the monopolar curved scissors (mcs) tip cover accessory. The reporter was unable to specify how the mcs tip cover accessory was damaged. There was no report of a fragment falling into the patient. No known impact or patient consequence was reported. Intuitive surgical inc. (isi) obtained the following additional information regarding the reported event: the mcs tip cover accessory was installed into the mcs instrument using an installation tool. The mcs instrument operated without issue and no arcing was observed during the procedure.

• Brand Name: NONE
• Type of Device: TIP COVER ACCESSORY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 9235274
• MDR Text Key: 191741816
• Report Number: 2955842-2019-10854
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 400180-14
• Device Lot Number: M90190410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial