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

Model Number FGS-0313

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, when the plunger was pressed, the capsule would not detach.The customer broke the safety clip to remove the capsule and the patient experienced a small mount of bleeding from the suction.The bleeding was similar to what would be expected from a biopsy.No intervention was required to stop the bleeding, it stopped on its own.Another capsule was used to without issues, and repeat procedure was not necessary.The customer noted that 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.

Manufacturer Narrative

Evaluation summary: this report is based on information provided by medtronic investigation personnel and (b)(4) device arriving in bio lab.(b)(4) 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 the plunger was pressed, the capsule would not detach.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
• 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 80301 ; 3035306582
• MDR Report Key: 8580924
• MDR Text Key: 144138422
• Report Number: 9710107-2019-00203
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: 07290101361688
• 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: user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 43101Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 05/05/2019
• Supplement Dates Manufacturer Received: 05/22/2019
• Supplement Dates FDA Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2018
• 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: 46 YR
• Patient Weight: 81