MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. TIP COVER ACCESSORY; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY

Model Number 400180-12

Device Problem Split (2537)

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

Event Date 03/17/2014

Event Type  malfunction  

Manufacturer Narrative

The instrument was returned and evaluated.Per the customer reported complaint, failure analysis investigation observed that the tip cover accessory showed two symmetrical tears at the distal opening of the tip cover.Each of the tears were different in length, one was approximately.083 long and the other was approximately.1150 long.Evidence not conclusive but it's likely the tear occurred where the blade made constant contact with the clear section of the tip cover at high force in one direction, possibly in the yaw orientation.An additional observation not reported by the site was that the tip cover accessory exhibited mechanical damages at the distal end of tip cover.The tip cover showed multiple areas at the silicone portion of the tip cover with pieces were missing.The damages did puncture hole through tip cover surface.Evidence not conclusive but it's likely damages occurred from collision from another instrument.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 mdr reportable event; however; the damage to the instrument accessory tip cover found during failure analysis investigation could cause or contribute to an adverse event if the failure mode were to recur.

Manufacturer Narrative

The tip cover accessory was returned, but the investigation has not been completed.A follow-up mdr will be submitted once the investigation is finalized.

Event Description

It was reported that during a da vinci surgical procedure, the customer noted that the transparent part of the tip cover was found split within the first 60 mins of operation.There was no report of fragments falling into a patient.There was no allegation of any harm, injury, or adverse outcome to a patient.

• Brand Name: TIP COVER ACCESSORY
• 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: 3803586
• MDR Text Key: 12012812
• Report Number: 2955842-2014-02905
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180-12
• Device Lot Number: M10131003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1