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

Model Number 420343-01

Device Problem Split (2537)

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

Event Date 12/26/2013

Event Type  malfunction  

Event Description

It was reported that during set up and prior to starting a da vinci surgical procedure the shaft of a thoracic grasper was splintering.The instrument was not used in the case.Nothing reportedly fell into a patient and no patient harm, adverse outcome or injury was reported.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis found the instrument main tube had a piece of insulation missing close to the distal end measuring.093 x 0.63.No other damage was found.The customer reported complaint does not itself constitute a mdr reportable event; however; missing insulation, if to recur could cause or contribute to an adverse event.

• Brand Name: THORACIC 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: 3590873
• MDR Text Key: 4188988
• Report Number: 2955842-2014-00448
• 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: 12/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420343-01
• Device Lot Number: S10130606 187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2013
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/26/2013
• Initial Date FDA Received: 01/24/2014
• 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