MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. SINGLE-SITE CURVED CANNULA ACCESSORY; ENDOSCOPIC INSTRUMENT ACCESSORY

Model Number 428061-03

Device Problem Malposition of Device (2616)

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

Event Date 03/26/2014

Event Type  malfunction  

Event Description

It was reported that during a da vinci surgical procedure, it was noted that the curved canula accessory rotated and did not orient in the correct direction.The planned surgical procedure was completed.There was no report of fragments falling into the patient.There was no patient harm, adverse outcome or injury reported.

Manufacturer Narrative

The cannula accessory was returned and evaluated.Failure analysis investigation found the cannula accessory had a weld defect.The cannula rotated, and the bowl and tube were able to be completely separated.No other damage was found.

• Brand Name: SINGLE-SITE CURVED CANNULA ACCESSORY
• Type of Device: ENDOSCOPIC 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: 3766839
• MDR Text Key: 4470300
• Report Number: 2955842-2014-02459
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K112208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 428061-03
• Device Lot Number: VE121508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• 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