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

Model Number 420093-08

Device Problem Malposition of Device (2616)

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

Event Date 10/15/2013

Event Type  malfunction  

Event Description

It was reported that during a da vinci surgical procedure, the prograsp forceps instrument's cable was dislodged outside of the grasp.Nothing reportedly fell into a patient.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis was unable to confirm the reported complaint.No loose or derailed cables were found at the instrument's tip.An additional observation not reported was one grip cable was frayed at the distal idler pulley.Frayed strands stuck out at the instrument's wrist.Other cables at the wrist were not damaged.No other damage was found.The customer reported complaint does not itself constitute a mdr reportable event; however; the frayed cable, 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: 3699336
• MDR Text Key: 4338043
• Report Number: 2955842-2014-01781
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• 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: M10111109 780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• 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