MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. PROGRASP FORCEPS INSTRUMENT; ENDOSCOPIC INSTRUMENT

Model Number 420093-08

Device Problem Split (2537)

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

Event Date 01/28/2014

Event Type  malfunction  

Event Description

It was reported that the prograsp forceps instrument cable was noted to be split and derailed after a da vinci prostatectomy procedure.No patient harm, adverse outcome or injury was reported.

Manufacturer Narrative

The instrument was returned and evaluated.Per the customer reported complaint, failure analysis found that the one grip open cable was frayed at the distal idler pulley.The frayed strands stuck out at the wrist.Failure analysis also observed that the distal idler pulley exhibited a particular indentation located at the edge where the grip cable shows damage.The evidence was inconclusive but the frayed grip cable and pulley indentation may have been damaged by coming into contact with other instruments/objects.The evidence was inconclusive, but the damage was likely due to mishandling/misuse.Failure analysis also observed that the pitch up cable was frayed at the distal clevis hub.The small frayed strands stuck out at the wrist.Failure analysis also observed that the distal end of the main tube had various scratch marks with light material removal.The scratches were.174 -.211 in length and not aligned with the tube axis.No other damage was found.The endowrist instruments instructions for use (ifu) specifically states: general precautions and warnings handle instruments with care.Avoid mechanical shock or stress that can cause damage to the instruments.The customer reported complaint does not itself constitute a mdr reportable event; however, the damaged cable and/or tube abrasions, found during failure analysis evaluation could likely cause or contribute to an adverse event if the failure mode were to recur.

• Brand Name: PROGRASP FORCEPS 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: 3648680
• MDR Text Key: 4287261
• Report Number: 2955842-2014-01182
• 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,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420093-08
• Device Lot Number: M11130814 507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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
• Treatment: DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES
• Patient Age: 60 YR