MAUDE Adverse Event Report: OBTECH MEDICAL SARL_

Catalog Number SAGBX

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure, additional (2564)

Event Type  Injury  

Event Description

It was reported that after a gastric band procedure, the part of the gastric band in contact with the stomach (lower part of the band) present two rigid parts (lower and higher, so there is not pressure with the refill of sterile physiologic serum through the reservoir.This caused a necrosis in the external face of the stomach and consequently inclusion of the band in the gastric cavity.The symptoms of this problem are repetitive, infections in the reservoir zone.They consider that the treatment to solve this problem is the removal of the gastric band.They also reported a failure in the joint of the band and the reservoir wire.This failure causes that the gastric band is not filled with physiologic serum so the band is not working appropriately.

Manufacturer Narrative

(b)(4): information not available, device not returned for analysis.Should the information be provided later, a supplemental medwatch will be sent.

• 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: 4476421
• MDR Text Key: 5399956
• Report Number: 3005992282-2015-00003
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SAGBX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1