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

Model Number FGS-0312

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Injury (2348); Blood Loss (2597); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the capsule failed to attach.There was no reported patient outcome.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the capsule failed to attach.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.The doctor used a roth net to retrieve the capsule from the stomach after it was noted to be detached when capsule placement was confirmed.There was some evidence of pin prick blood in the esophagus.Lubrication was used to facilitate placement of the capsule and the delivery system and capsule will be returned for investigation.

Manufacturer Narrative

Additional information: d10, e1(first name, last name), e4 (email), g4, h3, h6 h3.Evaluation summary: this report is based on information provided by medtronic investigation personnel and the sample that arrived.One bravo device was received for evaluation.The returned sample met specification as received by medtronic.The visual inspection found that the delivery system is broken.The customer reported that the capsule failed to attach.The reported condition was not confirmed.The investigation of the returned equipment identified that the plunger is not connected to the handle - this is due to user mishandling of turning the handle more than 1/8 of turn.The investigation identified the root cause of the reported event to be mishandling.The user has contradicting the instructions for use (ifu).The ifu states: pressing down on the plunger too slowly may result in the capsule not properly attaching to the patient¿s esophagus or not detaching from the delivery device.Do not rotate the plunger while depressing it.A review of the device history records indicated that this serial/lot number was released meeting all specifications as manufactured.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 9492948
• MDR Text Key: 175119402
• Report Number: 9710107-2019-00624
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361695
• UDI-Public: 07290101361695
• Combination Product (y/n): N
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2020
• Device Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Device Lot Number: 46939Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention