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

Model Number 420093-11

Device Problems Loss of Power (1475); Material Too Rigid or Stiff (1544); Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

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

Event Date 06/19/2014

Event Type  malfunction  

Event Description

It was reported that during a da vinci hysterectomy procedure, the prograsp forceps instrument was not working right, stiff/jammed cable seized motion.There were no reports of fragments falling 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.Per the customer reported complaint, failure analysis investigation found the grip cable derailed at the clamping pulley when the housing was removed.The pulley did not exhibit any wear.Yaw motion was non intuitive as a result.An additional finding was various scratches on the distal end of the main tube exhibiting light material removal.The scratches were not axially aligned with the tube axis.No other damage was found.The customer reported complaint does not itself constitute a mdr reportable event; however; the tube abrasions with material removed, 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: 4000595
• MDR Text Key: 19925845
• Report Number: 2955842-2014-04883
• 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: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420093-11
• Device Lot Number: N10140411 511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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
• Patient Age: 62 YR
• Patient Weight: 83