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

Model Number FGS-0313

Device Problems Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: though no equipment was received for evaluation, a copy of the study was provided.Based on the data that was collected during the procedure, the recording was 69:10 hours in duration of a scheduled 96 hours.For the duration of the recording gaps in the signal were noted.As no equipment was returned, the cause of the failure cannot be reliably determined, but could have been caused by the following: a.Recorder malfunction ¿ due to a failure in the internal components inside the recorder, the ability to pick bravo capsule signal was damaged b.Capsule failure - due to failure on capsule¿s internal components, the ability of the capsule to function properly was damaged c.It can be some systematic communication error between capsule and recorder a review of the device history record indicates that the product was released meeting finished product specification.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they have a study with multiple large gaps in the tracing.Technical support was able to connect to the customer's computer and transfer a copy of the study for review, which confirmed there were several large gaps.There was no harm to the patient or the user, but a repeat procedure is necessary due to the device failure.

• 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 ; 5920 longbow drive; boulder, CO 80301 ; 7632104064
• MDR Report Key: 7616378
• MDR Text Key: 111668566
• Report Number: 9710107-2018-00778
• Device Sequence Number: 1
• Product Code: FFT
• 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: Other
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 36078Q
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2017
• 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: 52 YR
• Patient Weight: 60