MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. DEXTRUS HAND ACCESS SYSTEM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number FLR02

Device Problems Air Leak (1008); Break (1069)

Patient Problem Surgical procedure (2357)

Event Date 04/20/2015

Event Type  Injury  

Event Description

It was reported that during a hand-assisted laparoscopic radical gastrectomy procedure, air leakage was found after forty minutes.The surgeon checked the devices and found a breakage on device.There were no more like devices in the hospital at that time.The operation was converted to open to complete the procedure.The patient is now in stable condition.

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.At the time of this submission, the device has not been returned for analysis.Photographic conclusion: based on the photographic evidence, the event description of a breakage (torn) flr02 can be confirmed.

Manufacturer Narrative

(b)(4).Retractor sheath.The analysis results of the flr02 found that it was received with the retractor sheath torn.In addition, a hap02 device was returned in good condition.Upon visual inspection, the tear was observed to initiate 2 inches below the upper retractor ring and continued toward the lower retractor ring.No conclusion could be reached as to what may have caused the found condition.

• Brand Name: DEXTRUS HAND ACCESS SYSTEM
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4738090
• MDR Text Key: 19721998
• Report Number: 3005075853-2015-02713
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K070198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2019
• Device Catalogue Number: FLR02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR