MAUDE Adverse Event Report: OBTECH MEDICAL SARL_; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB32

Device Problem Disconnection (1171)

Patient Problem Surgical procedure, additional (2564)

Event Date 05/29/2013

Event Type  malfunction  

Event Description

It was reported that post implant a gastric band, the patient returned on (b)(6) 2014 with films and complained of pain in pelvic area.It was determiined that tube was disconnected from port.The port has been replaced.There was no adverse patient consequence reported.

Manufacturer Narrative

(b)(4).At the time of this submission, the device has not been returned for analysis.If the device or further details are received at a later date a supplemental medwatch will be sent.Additionnal information received from the sale rep: how many adjustments have received the patient? 0 -lost patient to follow on commitment from patient.The patient never had a fill.Was the locking connector attached to the port? yes, the initial implant had connector and strain relief properly connected.The surgeon demonstrated to rep on non sterile demo prior to revision.Where was the strain relief? still connected to locking connector upon second surgery.Is this the first incident of port disconnection? yes.

• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): OBTECH MEDICAL SARL_; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): OBTECH MEDICAL SARL; chemin-blanc 38; le locle CH-2 400; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3725234
• MDR Text Key: 4325253
• Report Number: 3005992282-2014-00019
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: RLZB32
• Device Lot Number: ZNMBCV
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2012
• 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