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 No Known Impact Or Consequence To Patient (2692)

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 detach from the delivery system.There was no reported outcome.

Manufacturer Narrative

Additional information: evaluation summary: this report is based on information provided by medtronic investigation personnel.The delivery and capsule was received for evaluation.A review of the product expiration date discovered this product was used before the expiration date.The returned sample met specification as received by medtronic.The visual inspection found the plunger to be broken by user.The customer reported bravo fail to attach.The investigation found the user turned the plunger more than 1/8 of a turn and caused it to break.The investigation identified the cause of the reported event to be user mishandling.The user has acted contradicting the instructions for use (ifu).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: 8244746
• MDR Text Key: 132981343
• Report Number: 9710107-2019-00022
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361695
• UDI-Public: 07290101361695
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2018
• Device Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Device Lot Number: 38208Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/14/2019
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2017
• 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