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 Laceration(s) of Esophagus (2398)

Event Date 05/21/2019

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 had a capsule which failed to attach that resulted to a temporary injury of a tear in the esophagus.No intervention was required, and a repeat procedure was performed on the same day.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.No lubrication was used to facilitate placement of the capsule and the delivery system and capsule will be returned for investigation.Another capsule was used to complete the procedure.There was no user harm.

Manufacturer Narrative

Evaluation summary: this report is based on information provided by medtronic investigation personnel and the sample that arrived.The bravo capsule was received for evaluation.The visual inspection found that the capsule arrived without the delivery system.The customer reported bravo fail to attach.The reported condition was confirmed.The investigation of the returned equipment could not identify anything that would have caused or contributed to the reported event.The capsule arrived without the delivery system.The investigation could not determine a root cause or a probable root cause for the customer's report based on the information provided.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: 8696598
• MDR Text Key: 147931659
• Report Number: 9710107-2019-00251
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: 07290101361688
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2020
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 44428Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 09/16/2019
• Supplement Dates FDA Received: 10/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2019
• 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: 61 YR