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

Model Number 420093-10

Device Problem Malposition of Device (2616)

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

Event Date 03/28/2014

Event Type  malfunction  

Event Description

It was reported that during reprocessing of the prograsp forceps instrument, the wire on the instrument jumped track.There were no frayed cables on the instrument observed and there was no report that any fragments from the instrument fell into a patient.

Manufacturer Narrative

The instrument was returned and evaluated.Per the customer reported complaint, failure analysis investigation found that the instrument's grip cable was derailed at the distal idler pulley.The grips still opened and closed, but the movement may not be precise.The cable derailment likely occurred as a result of the cable losing contact with the pulley during wrist articulation.The fleet angle between the proximal and distal pulleys may contribute to cable derailment.Failure analysis investigation also found the following additional damages to the instrument: the grip cable was frayed at the distal idler pulley.The frayed strands were sticking out at the wrist.The other cables at the wrist were not damaged.The edge of the distal pulley had mechanical indentations were the cable was derailed and the surface of the pulley exhibited visible scratches.It was concluded that the damage to the pulley was likely due to mishandling/misuse.No other damage was found.

• 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: 3785775
• MDR Text Key: 19969659
• Report Number: 2955842-2014-02724
• 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: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420093-10
• Device Lot Number: M10131123 945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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