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

Model Number	FGS-0313
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, they had a capsule which failed to attach.There was no harm to the patient, no intervention was required, and a repeat procedure was performed.There was nothing unusual about the patient or the procedure, the physician used a scope to determine capsule placement, and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.No lubrication was used to facilitate placement of the capsule.
Additional Manufacturer Narrative
Additional information: if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, they had a capsule which failed to attach.There was no harm to the patient, no intervention was required, and a repeat procedure was performed as they attempted to use another capsule.There was nothing unusual about the patient or the procedure, the physician used a scope to determine capsule placement, and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.No lubrication was used to facilitate placement of the capsule and the delivery system will be returned for investigation.
Additional Manufacturer Narrative
Evaluation summary: this report is based on information provided by medtronic investigation personnel.(b)(4) device was received for evaluation.The returned sample met specification as received by medtronic.The visual inspection found that the delivery system wire was bent.The customer reported that the capsule failed to attach.The reported condition was not confirmed.The investigation found the device to function normally and within specifications.The investigation found the device to function normally and within specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRAVO
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 8567494
• Report Number: 9710107-2019-00191
• Device Sequence Number: 2294687
• Product Code: FFT
• UDI-Device Identifier: 07290101361695
• UDI-Public: 07290101361695
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2020
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 44439Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 04/15/2019; 05/23/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 05/02/2019; 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 109