MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT; ENDOSCOPIC INSTRUMENT

Model Number 420230-04

Device Problem Malposition of Device (2616)

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

Event Date 06/11/2014

Event Type  malfunction  

Event Description

It was reported that the wire was derailed on the large hem-o-lok clip applier instrument.No patient harm, adverse outcome or injury was reported.

Manufacturer Narrative

The instrument was returned and evaluated.Per the customer reported complaint, failure analysis investigation observed that one grip cable on one side of the distal clevis was found to be derailed from the yaw pulley.The yaw motion was non-intuitive as a result.Other cables at wrist were not damaged.An additional observation not reported by site was that one instrument's grip cable was found to be frayed at the yaw pulley.The yaw motion was non-intuitive as a result.Other cables at wrist were not damaged.The customer reported complaint does not itself constitute a mdr reportable event; however; the damage to the instrument's grip cable found during failure analysis investigation could cause or contribute to an adverse event if the failure mode were to recur.

• Brand Name: LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT
• Type of Device: ENDOSCOPIC INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA 9408 6
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA 94086
• MDR Report Key: 3930987
• MDR Text Key: 20018789
• Report Number: 2955842-2014-04237
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420230-04
• Device Lot Number: M10130627 500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 06/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1