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

Model Number FGS-0313

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2018

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 attach.There was no harm to the patient and user, no intervention was required, and no repeat procedure was performed.There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.Lubricant was used to facilitate placement of the capsule and the delivery system and the capsule will be returned for investigation.

Manufacturer Narrative

Evaluation summary: this report is based on information provided by medtronic investigation personnel.One bravo ph capsule delivery device and one capsule were received for investigation.The returned sample met specification as received by medtronic.The visual inspection found the device to be broken.The customer reported they had a capsule which failed to attach.The reported condition was confirmed.The investigation of the returned equipment identified that the plunger is not connected to the handle - this is due to user mishandling of turning the handle more than 1/8 of turn.The investigation identified the cause of the reported event to be user mishandling.The user has contradicting the instructions for use (ifu).The ifu states: pressing down on the plunger too slowly may result in the capsule not properly attaching to the patient¿s esophagus or not detaching from the delivery device.Do not rotate the plunger while depressing it.A review of the device history records indicated that this serial/lot number was released meeting all specifications as manufactured.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: 9333656
• MDR Text Key: 167012980
• Report Number: 9710107-2019-00552
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: 07290101361688
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2019
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 41939Q
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2018
• 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: 72 YR
• Patient Weight: 81