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

Catalog Number RLZB32

Device Problem Material Fragmentation (1261)

Patient Problems Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 04/08/2015

Event Type  Injury  

Event Description

It was reported that after a laparoscopic band removal procedure, a piece of the device fell off in the patient when removing it two weeks ago.The patient was now complaining of abdominal pain.The ct scan showed a mass where the piece was supposed to be and the ultrasound revealed just a potential calcification tubular.The surgeon is going to schedule the patient for re-operation to remove the item that fell off.

Manufacturer Narrative

(b)(4).Device not returned for analysis should the information be provided later, a supplemental medwatch will be sent.Additional information was requested and the following was obtained: what is the patient¿s current status? discharged.What piece is missing from the device? what component of the device is said to remain inside the patient? strain relief.What events led to the decision made to leave the missing component inside the patient? patient returned for re-op and piece removed on (b)(6) 2015.Has the explanted device been discarded or can this be returned for investigation? no.What date was the device implanted? (b)(6) 2010.What date is the next surgery scheduled for? (b)(6) 2015.

Manufacturer Narrative

(b)(4).Upon evaluation of the photography, it was observed that the injection port was in the locked position, hooks were deployed and the locking connector was in place.The tubing strain relief was not present on the locking connector.The strain relief material is identified as silicone, and is certified by the manufacturer to be suitable for use in implant devices.This silicone material has been tested for long term implantability.

Manufacturer Narrative

(b)(4).

• Brand Name: ADJ GASTRIC BAND
• 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-24 00; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4751562
• MDR Text Key: 5768111
• Report Number: 3005992282-2015-00019
• 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: User Facility,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: RLZB32
• Device Lot Number: ZKDBLZ
• Other Device ID Number: 20705036004001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/16/2009
• 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