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

Model Number FGS-0312

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the capsule failed to dislodge from the delivery system after the firing procedure.They attempted to remove the delivery system and it made the patient cough, eventually the capsule was dissociated from the mucosa.There was no intervention required and a repeat procedure was performed on the same day using another capsule.There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure.A lubrication was used to facilitate placement of the capsule.There was a tear on the esophageal wall and it was a temporary injury.There was no user harm.

Manufacturer Narrative

Additional info:evaluation summary: this report is based on information provided by the complaint tracking system.The product sample was not returned to the medtronic laboratory, however, a picture was provided by the customer for analysis.The picture sample showed the calibration product.The customer reported that the capsule failed to dislodge from the delivery system after the firing procedure.They attempted to remove the delivery system and it made the patient cough, eventually the capsule was dissociated from the mucosa.The reported condition was confirmed.The failure 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 55441 ; 7632104064
• MDR Report Key: 8542316
• MDR Text Key: 142934389
• Report Number: 9710107-2019-00175
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: 07290101361688
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2020
• Device Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Device Lot Number: 44432Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2019
• 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: 26 YR