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 Code Available (3191)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when they fired during the procedure, the capsule failed to attach on the esophageal wall of the patient, it was removed by the use of the deliver catheter.The patient suffered a tear on the esophageal wall, and there was no user harm.A repeat procedure was done on the same day using another capsule.The customer noted the patient was not under anesthesia.The delivery system and capsule will be returned for investigation.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when they fired during the procedure, the capsule failed to attach on the esophageal wall of the patient, it was removed by the use of the deliver catheter.The physician noticed blood on esophageal wall and mentioned that there was a mild tear, and no intervention was needed to treat the tear.A repeat procedure was done on the same day using another capsule.The customer noted the patient was not under anesthesia.The delivery system and capsule will be returned for investigation.
Additional Manufacturer Narrative
Additional information: evaluation summary: this report is based on information provided by medtronic investigation personnel and bravo device arriving in bio lab.Bravo device was received for evaluation.The returned sample met specification as received by medtronic.The visual inspection found no notable conditions.The customer reported when they fired during the procedure, the capsule failed to attach on the esophageal wall of the patient, it was removed by the use of the deliver catheter.The investigation found the device to function normally and within specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when they fired during the procedure, the capsule failed to attach on the esophageal wall of the patient, and the capsule was removed by the use of the deliver catheter.The physician noticed blood on esophageal wall and mentioned that there was a mild tear, and no intervention was needed to treat the tear.No repeat procedure was done on a different day as another capsule was used to proceed with the procedure.The customer noted the patient was not under anesthesia.

• Brand Name: BRAVO
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 8457544
• Report Number: 9710107-2019-00124
• Device Sequence Number: 2887393
• Product Code: FFT
• UDI-Device Identifier: 07290101361695
• UDI-Public: 07290101361695
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K102543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2019

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: 10/07/2019
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 07290101361688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/02/2019; 05/22/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/18/2019; 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1