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 05/15/2014

Event Type  malfunction  

Event Description

It was reported that in central processing, it was observed that the tips on the prograsp forceps instrument will not go straight.There was no report of fragments falling into a patient.There was no patient harm, adverse outcome or injury reported.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis found the instrument's grip cable to be derailed.The grip cable was derailed at the distal idler pulley.Yaw motion was non-intuitive as a result.The other cables at the wrist of the instrument were undamaged.Failure analysis investigation also found the instrument's main tube had scratch marks/abrasions.The distal end of the main tube had various scratch marks with light material removal.The scratches were not aligned with the tube axis.No other damage was found.The customer reported complaint does not in itself constitute a mdr reportable event; however, the various scratch marks on the main tube with light material removal found during failure analysis if to recur could cause or contribute to an adverse event.

• 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: 3830852
• MDR Text Key: 4447182
• Report Number: 2955842-2014-03202
• 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: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• 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: M10140120 248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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