MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH

Model Number FGS-0312

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a capsule which failed to detach from the delivery device and it was not possible to remove the device from the patient, the emergency handle had to be broken.There was no harm to the patient and no adverse effects as scope re-passed to check if capsule was attached to esophagus and it was seen to be securely attached from a distance of 3-4 inches away, no intervention was required, and no repeat procedure was performed.The procedure was completed without significant delay as handle broken when resistance felt on trying to withdraw delivery device.There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure, it passed before delivery device passed, and esophagus was deemed to be normal.No lubrication was used to facilitate placement of the capsule and the delivery system and capsule will be returned for investigation.The recorder worked correctly during the previous procedure.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

This report is based on information provided by the complaint tracking system.Several bravo devices arrived for evaluation in a bag, it is not possible to associate the devices to their sr.A review of the product expiration date was performed based on lot number provided in gch.Per tech support description there is no enough information to determine if product whether product meet specification or not.Since inadequate sample arrived, a visual inspection was not performed.The customer reported they had failed to attach bravo capsule.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.An evaluation was not performed since the product sample did not arrive for investigation in the proper fashion the enables investigation.The failure root cause was not found since the product sample did not arrive for investigation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth,mn, CT 55441 ; 7632104064
• MDR Report Key: 7675527
• MDR Text Key: 113875310
• Report Number: 9710107-2018-00827
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361695
• UDI-Public: 07290101361695
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Device Lot Number: 37863Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• 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
• Patient Age: 23 YR