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

Model Number FGS-0636

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

This report is based on information provided by medtronic investigation personnel and the sample that arrived.Bravo device (capsule and delivery) was received for evaluation.The returned sample met specification as received by medtronic.The visual inspection found no notable conditions.The customer reported they had a capsule which failed to attach.The reported condition was not confirmed.A review of the product expiration date discovered this product was used before the expiration date.Since inadequate sample was returned for investigation it is impossible to determine if product meet specs or not.The investigation did not find any fault in the returned equipment.A review of the device history records indicated that this serial/lot number was released meeting all specifications as manufactured.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.There was bleeding on the esophagus of the patient and they used a resolution clip to stop the bleeding.They used a roth net to retrieved the capsule.There was nothing unusual about the patient or the procedure, scope was used by the physician to place the capsule, 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.

• Brand Name: BRAVO CAPSULE
• 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: 8778779
• MDR Text Key: 150669953
• Report Number: 9710107-2019-00325
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369714
• UDI-Public: 07290101369714
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2020
• Device Model Number: FGS-0636
• Device Catalogue Number: FGS-0636
• Device Lot Number: 44764F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 79