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

Model Number FGS-0313

Device Problems Failure to Transmit Record (1521); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, they were getting a "capsule mismatch" error when they attempted to begin a study.They attempt to get the recorder to recognize the capsule by selecting "ok".It seemed that the capsule was not transmitting.The procedure was started with no problem.The recorder and capsule matched without any problem and the recording was started on the patient in the room.When the patient was transferred to recovery room, the recovery room nurse attempted to show the patient the buttons on the recorder to press for certain activities, but they noticed that the recorder was not responding.The recorder showed a message stating that the capsule was not within range or the recorder could not find the capsule.After the error, they could not reconnect the capsule and recorder.The patient also had something to drink by that point so they could not redo the procedure immediately.The patient was scheduled 3 days later.The surgeon performed the egd (esophagogastroduodenoscopy) procedure and it was noted that the capsule was attached and intact on the esophageal wall.It was removed by the surgeon and another capsule was placed.The 2nd procedure was performed without any problems.The recorder worked correctly on all their prior cases.They told that the problem was with the capsule.There was no patient and user harm.

• 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: 8832307
• MDR Text Key: 152378214
• Report Number: 9710107-2019-00347
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: 07290101361688
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2019
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 453380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2019
• 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: 39 YR
• Patient Weight: 102