MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. SINGLE-SITE 5 X 250 MM CURVEDCANNULA, ARM 1; ENDOSCOPIC ACCESSORY

Model Number 428071-03

Device Problems Nonstandard Device (1420); Malposition of Device (2616)

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

Event Date 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the instrument involved with this complaint and completed investigations.Failure analysis investigations found that the tube of the returned cannula moved with respect to the bowl feature.The weld that joins tube and bowl was found to be cracked around the circumference.No other damage was found.The returned affected part has been identified as an affected device related to isi field safety notice 2955842-02-28-2014-001-r.The notice was sent to the site's robotics coordinator on 03/25/2014 and on 04/11/2014 an acknowledgment receipt was received from the site's robotics coordinator indicating that they had no affected product.The customer reported complaint does not itself constitute a mdr reportable event; however, the weld defect found during failure analysis evaluation could likely cause or contribute to an adverse event if the failure mode were to recur.

Event Description

It was reported that during a da vinci assisted hysterectomy procedure, the customer observed that the cannula was pointing in the incorrect direction during installation of the 250mm single site curved cannula into the port.The customer installed the cannula into another port but the issue recurred.The customer then installed a 300mm single site curved cannula and the issue was resolved.The planned surgical procedure was completed and there was no report of any patient harm, adverse outcome or injury.On 09/18/2015, intuitive surgical, inc.(isi) contacted the isi clinical sales representative (csr) who initially reported this complaint.According to the csr, the customer noted that the cannula was misaligned after it was installed.The site inspected the cannula after it was removed and there were no issues observed.The top of the cannula did not spin or move on the shaft and the cannula did not exhibit any damage.

• Brand Name: SINGLE-SITE 5 X 250 MM CURVEDCANNULA, ARM 1
• Type of Device: ENDOSCOPIC ACCESSORY
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.; 950 kifer rd.; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale, CA
• MDR Report Key: 5167569
• MDR Text Key: 29304890
• Report Number: 2955842-2015-01317
• 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: other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 428071-03
• Device Lot Number: VE123014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2955842-02-28-2014-001-R
• Patient Sequence Number: 1