MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. PERMANENT CAUTERY HOOK INSTRUMENT; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 428090-12

Device Problem Malposition of Device (2616)

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

Event Date 06/04/2014

Event Type  malfunction  

Event Description

It was reported that during a da vinci surgical procedure, a derailed cable was observed on the permanent cautery hook instrument.There was no report of fragments falling into the 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.Failure analysis investigation was unable to confirm the reported complaint of a derailed cable.The instrument does not have cables or wires outside of the housing; thus, no cables or wires are visible.Failure analysis investigation found that the instrument's main tube was broken at the connection with the clevis.There appeared to be material missing from the main tube as a result of the damage.It was concluded that the 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 itself constitute a mdr reportable event; however, the damage to the main tube, found during failure analysis investigation, could likely cause or contribute to an adverse event, if the malfunctions were to recur.

• Brand Name: PERMANENT CAUTERY HOOK 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: 3917405
• MDR Text Key: 4514123
• Report Number: 2955842-2014-04123
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K130726
• 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: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 428090-12
• Device Lot Number: S10131109 503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 06/16/2014
• 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