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 03/19/2014

Event Type  malfunction  

Event Description

It was reported that during a da vinci nephrectomy procedure, the customer noted that the prograsp forceps instrument was found difficult to move.The instrument was replaced to complete the surgery.There was no report of fragments falling into a patient.There was no allegation of any harm, injury, or adverse outcome to a patient.

Manufacturer Narrative

The instrument was returned and evaluated.Per the customer's initial report of difficult to move, failure analysis investigation observed that the intuitive motion was not being experienced because of a broken pitch cable at the wrist of the instrument.The cable segment that contains the crimp was still installed in the clevis.The clevis did not exhibit any damage or wear marks.An additional observation not reported by the customer was insulation damage to the distal end of the main tube.Material was missing.The surface of main tube appeared to be scraped off at various areas.No other damage was found.The customer reported complaint does not itself constitute a mdr reportable event; however; the damage to the instrument's pitch cable and/or main tube found during failure analysis investigation could 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: 3814139
• MDR Text Key: 20857976
• Report Number: 2955842-2014-03025
• 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: 04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• 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: M10113114 182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/29/2014
• 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
• Patient Age: 54 YR