MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST LARGE NEEDLE DRIVER

Model Number 420006-08

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

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

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc. (isi) received the instrument involved with this complaint and completed the device evaluation. Failure analysis investigation was able to confirm the reported issue. The instrument was found to have a broken pitch cable at the distal clevis hub. The broken cable segment that contained the crimp was missing from the clevis. A device history record (dhr) review for this device was conducted and did not find any non-conformances that would affect any material of the final product and/or the quality or performance of the instrument. The customer reported complaint does not itself constitute an mdr reportable event; however, the broken pitch cable found during failure analysis could cause or contribute to an adverse event if the failure mode were to recur.

Event Description

It was reported that prior to the start of a da vinci-assisted adrenalectomy procedure, the large needle driver instrument was noted to have a damaged cable which led to inadequate movement. The instrument was not used in the procedure. The procedure was completed with no report of patient harm, adverse outcome or injury.

• Brand Name: ENDOWRIST LARGE NEEDLE DRIVER
• Type of Device: LARGE NEEDLE DRIVER
• 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: 7644212
• MDR Text Key: 112566349
• Report Number: 2955842-2018-10330
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 420006-08
• Device Lot Number: N13160726 823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse