MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ REALIZE ADJ GASTRIC BAND STR; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB22

Device Problems Crack (1135); Material Separation (1562)

Patient Problem Failure of Implant (1924)

Event Date 01/15/2014

Event Type  malfunction  

Event Description

It was reported that post implant, the band was not filling upon adjustments.On (b)(6), 2014, it was discovered that the band tubing was cracked and separated from the port.It is unknown what method was used to initially identify the separation.Once discovered, a new port was placed and the original band tubing reconnected to the new port.The original port has been discarded.

Manufacturer Narrative

(b)(4): information unavailable.

• Brand Name: REALIZE ADJ GASTRIC BAND STR
• 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: kathy rice ; 4545 creek rd; cincinnati, OH 45242-2803 ; 5133373299
• MDR Report Key: 3613611
• MDR Text Key: 20700230
• Report Number: 3005992282-2014-00008
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RLZB22
• Device Lot Number: ZJKBBC
• Other Device ID Number: BATCH #: UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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