MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. COBRA GRASPER INSTRUMENT; ENDOSCOPIC INSTRUMENT

Model Number 420190-07

Device Problem Malposition of Device (2616)

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

Event Date 07/18/2014

Event Type  malfunction  

Event Description

It was reported in central processing that a wire was hanging out of the tip end of the cobra grasper instrument.There was no report of fragments falling into the patient.There was no patient harm, adverse outcome or injury reported.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis investigation found the instrument's grip cable was broken.One grip cable was broken at the distal clevis hub.The cable segment stuck out at the wrist.The distal clevis hub did not exhibit any wear.The other cables at the wrist were not damaged.Failure analysis investigation also found the instrument's main tube had scratch marks and abrasions.The distal end of the main tube had various scratch marks with light material removal.The scratches were not aligned with the tube axis.No other damage was found.The customer reported complaint does not in itself constitute a mdr reportable event; however; the broken cable and damage to the main tube if to recur could cause or contribute to an adverse event.

• Brand Name: COBRA GRASPER 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: 3975708
• MDR Text Key: 19926238
• Report Number: 2955842-2014-04682
• 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: 07/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420190-07
• Device Lot Number: M10120510 150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• 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