MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI XI TIP-UP FENESTRATED GRASPER

Model Number 470347-09

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc. (isi) received the instrument involved with this complaint and completed the device evaluation. Failure analysis confirmed the customer reported failure. The instrument was found to have a broken pitch cable at the distal clevis hub. The broken cable segment that contains the crimp was missing from clevis. The clevis did not exhibit any damage or wear marks. Other cables at the wrist were not damaged. A device history record (dhr) review for the device involved with the complaint has been completed. No non-conformances were identified to be related to this complaint.

Event Description

It was reported that during central processing, the customer noted a broken cable on the tip up fenestrated grasper instrument. There was no report of patient involvement.

• Brand Name: DA VINCI XI
• Type of Device: TIP-UP FENESTRATED GRASPER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale ; 4085232100
• MDR Report Key: 7478732
• Report Number: 2955842-2018-10169
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112496
• UDI-Public: (01)00886874112496(10)N10180119
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 470347-09
• Device Lot Number: N10180119 0039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Treatment(s): DA VINCI INSTRUMENTS AND ACCESSORIES