MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. PK DISSECTING FORCEPS INSTRUMENT; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 420227-05

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2014

Event Type  malfunction  

Manufacturer Narrative

The instrument was returned and evaluated.Per the customer reported complaint, failure analysis observed that the pitch up cable was found to be broken at the distal clevis hub.The cable segment that contains the crimp was still installed in clevis.The clevis did not exhibit any damage or wear marks.Additional observation was main tube damage.The distal end of the main tube exhibited various scratch marks with light material removal and a rough surface finish.The scratches were short in length and were not aligned with the tube axis.Failure analysis concluded that damage was likely due to mishandling.The endowrist® instruments instructions for use (ifu) specifically states: general precautions and warnings handle instruments with care.Avoid mechanical shock or stress that can cause damage to the instruments.The customer reported complaint does not itself constitute a reportable event; however, the broken cable and the additional finding of main tube damage with material removed, found during failure analysis could likely cause or contribute to an adverse event if to reoccur.

Event Description

It was reported that during a da vinci surgical procedure, a split cable was found on the pk dissecting forceps instrument.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.

• Brand Name: PK DISSECTING FORCEPS INSTRUMENT
• Type of Device: ENDOSCOPIC ELECTROSURGICAL 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: 4000150
• MDR Text Key: 19456731
• Report Number: 2955842-2014-04880
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K061260
• 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: 420227-05
• Device Lot Number: N10140508 935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2014
• 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: 05/01/2014
• 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