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

Model Number FGS-0313

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Discomfort (2330)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation: na/others.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 detach from the delivery device.There was some mild discomfort to the patient and a tiny amount of blood in the suction and on the drapes.Further observation as intervention was required following minimal bleeding, but the patient is stable and there was no harm to anybody, and a repeat procedure was performed as the procedure was terminated at the time of incident.They used a third capsule, but the patient was unable to tolerate the third attempt.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.A lubricant was used to facilitate placement of the capsule and the capsule was cleaned thoroughly with disinfectant wipes and will be returned together with the delivery device for investigation.

Manufacturer Narrative

Corrected information:if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional: (street 1, mfr.City, region, postal code),evaluation summary: this report is based on information provided by medtronic investigation personnel and the sample that arrived.One bravo capsule and one bravo delivery device were received for evaluation.A review of the product expiration date discovered this product was used before the expiration date.The returned sample met specification as received by medtronic.The visual inspection found no notable conditions.The customer reported bravo fail to attach to patient's esophagus.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.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, CO 55441 ; 7632104064
• MDR Report Key: 7734768
• MDR Text Key: 115765789
• Report Number: 9710107-2018-00875
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: 7290101361688
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 37874Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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