OBTECH MEDICAL SARL_ GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
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Catalog Number BD3XV |
Device Problems
Air Leak (1008); Hole In Material (1293)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/15/2014 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Additional information: port applier, port & red cap in unopened packaging and band with full catheter attached was returned.The lot number etched on the band is zrcbbd.The complaint alleges balloon leakage.Leak test performed and the product failed the test.A leak was evident on the band.There is a minute hole visible on the band.This is a clean cut hole, not a tear, which may suggest needle / sharp object perforation.A device history records (dhr) review was carried out and no discrepancies in relation to this event were noted on the file.A review of the manufacturing process was performed and it is noted that all products are 100% leak tested prior to release; therefore it is unlikely that a manufacturing issue contributed to the reported event.
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Event Description
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It was reported that prior to use of the device in a gastric banding procedure, when the scrub nurse pre-tested the device (put band in bowl of water), some bubbles came out and there was one little hole in the band.A new device was opened and used instead.No patient involvement.
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Manufacturer Narrative
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(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.
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Search Alerts/Recalls
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