MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. HARMONIC ACE CURVED SHEARS INSERT; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY

Model Number 400272-02

Device Problem Split (2537)

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

Event Date 04/01/2014

Event Type  malfunction  

Event Description

It was reported that in central processing, it was noted that the sealing edge of the working jaw split apart on the harmonic ace curved shears insert accessory.There was no report of fragments falling into the patient.There was no patient harm, adverse outcome or injury reported.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis investigation found the harmonic ace insert had teflon pad damage.The teflon pad was peeling off, when pushed down, no material appeared to be missing.Failure analysis concluded that the teflon pad damage was likely due to mishandling/misuse.No other damage was found.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 in itself constitute a mdr reportable event; however; the teflon pad damge if to recur could cause or contribute to an adverse event.

• Brand Name: HARMONIC ACE CURVED SHEARS INSERT
• Type of Device: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY
• 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: 3772770
• MDR Text Key: 4438729
• Report Number: 2955842-2014-02541
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K112584
• 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: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400272-02
• Device Lot Number: M10130726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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