MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND SYSTEM TUBING ACCESSORY KIT; ADJUSTABLE GASTRIC BAND TUBING

Model Number	A-20401
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Taper ii.The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Based on the serial number provided, the connector type is assumed to be a taper ii.If returned, visual examination may confirm or determine another taper type associated with this event.Device labeling addresses the reported event as follows: precautions: the lap-band ap system is for single use only.Do not use a band, access port, needle or calibration tube that appears damaged (cut, torn, etc.) in any way.Do not use any of the above components if the package has been opened or damaged or if there is any evidence of tampering.If packaging has been damaged, the product may not be sterile and may cause an infection.The band, access port and calibration tube may be damaged by sharp objects and manipulation with instruments.A damaged device must not be implanted.For this reason, a stand-by device should be available at the time of surgery.
Event or Problem Description
Reported as: the physician was performing a lap-band system tubing revision surgery, and upon opening the unit, noted "lap-band system tubing kit reference number (b)(4) was defective.Part number ss connector the lumen was not patent.Scrub tech was irrigating the lumen and was not able to get the tubing to work.The tubing was moved to a table and a metal chard came out while irrigating.Defective tubing (connector) caused the patient to have another surgery to correct the tubing." the patient was scheduled at a later time to have the lap-band tubing replaced.

• Brand Name: LAP-BAND SYSTEM TUBING ACCESSORY KIT
• Common Device Name: ADJUSTABLE GASTRIC BAND TUBING
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. captial of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 5875720
• Report Number: 3006722112-2016-00245
• Device Sequence Number: 13573507
• Product Code: LTI
• UDI-Device Identifier: 10811955020060
• UDI-Public: 10811955020060
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/29/2016

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
• Operator of Device: Physician
• Device Expiration Date: 11/11/2016
• Device Model Number: A-20401
• Device Catalogue Number: A-20401
• Device Lot Number: 2670461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2016
• Initial Report FDA Received Date: 08/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 107