MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI SYSTEM; PK DISSECTING FORCEPS INSTRUMENT

Model Number 8MM, IS200

Device Problems Break (1069); Device Inoperable (1663); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 07/21/2015

Event Type  malfunction  

Event Description

Pk dissecting forceps (which has a 20 use lifespan; this was use #1.): pk forcep was inserted through trocar into the pt.During use, the pk jammed/didn't work and the jaws of the pk were stuck open.Called the local rep for intuitive, the previous rep and the hotline.Hotline instructed to use the sterile emergency wrench to free the pk.The wrench loosened the screw, located on the exterior part of the pk instrument on the outside of the pt.The emergency wrench caused the jaws to close the pk.The pk was removed from the pt's cavity.Per intuitive's eval of the pk forcep, it was determined that a "broken pitch cable at the distal clevis hub.The cable segment that contained the crimp was no longer installed in clevis".The broken pitch cable had not been located.Hysterectomy (robotic).

• Brand Name: DA VINCI SYSTEM
• Type of Device: PK DISSECTING FORCEPS INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; sunnyvale CA 94086
• MDR Report Key: 5124137
• MDR Text Key: 27477096
• Report Number: MW5056766
• Device Sequence Number: 1
• Product Code: NAY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/28/2015

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: 8MM, IS200
• Device Lot Number: N10150605 903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR