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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH
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GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH Back to Search Results
Model Number FGS-0636
Device Problems Loss of or Failure to Bond (1068); Positioning Failure (1158)
Patient Problems Radiation Exposure, Unintended (3164); No Code Available (3191)
Event Date 01/27/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the capsule was expelled when the patient forcefully coughed just after placement, and it was found on the floor.An endoscopy had been performed to confirm the position of the capsule prior to its placement using an endoscope and the esophagus appeared to be normal with some esophagitis.The insertion device was slightly difficult to pass that it took the customer 2 attempts due to head positioning and thick neck.The customer had to perform an x-ray to confirm the capsule was not retained in airway or it was early released into the stomach, and the capsule was not seen in x-ray.The patient was still sedated from the original procedure, some additional anesthesia was given to continue sedation slightly longer, and a new capsule was successfully deployed when they confirmed based on the visual of tissue irritation 6 centimeter above the gastroesophageal junction where it was deployed.No lubricant was used to facilitate placement of the capsule and the delivery system and capsule will be returned for investigation.There was no user harm.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the capsule was expelled when the patient forcefully coughed just after placement, and it was found on the floor.An endoscopy had been performed to confirm the position of the capsule prior to its placement using an endoscope and the esophagus appeared to be normal with some esophagitis.The insertion device was slightly difficult to pass that it took the customer 2 attempts due to head positioning and thick neck.The customer had to perform an x-ray to confirm the capsule was not retained in airway or it was early released into the stomach, and the capsule was not seen in x-ray.The patient was still sedated from the original procedure, some additional anesthesia was given to continue sedation slightly longer, and a new capsule was successfully deployed when they confirmed based on the visual of tissue irritation 6 centimeter above the gastroesophageal junction where it was deployed.No lubricant was used to facilitate placement of the capsule and the delivery system and capsule will be returned for investigation.There was no user harm.
 
Manufacturer Narrative
Additional information: d10, g4, h3, h6.H3 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.The customer reported they had a capsule which failed to attach.The capsule was expelled when the patient forcefully coughed just after placement, and it was found on the floor.The reported condition was not confirmed.The investigation found the device to function normally and within specifications.The plunger was stuck at the second slit and was fully released (6 ribs).The vacuum reached 510 mmhg and was applied for at least 30 seconds, the wire that holds the capsule was completely off and the foam gasket was in good condition.A review of the device history records indicated that this se rial/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.
 
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Brand Name
BRAVO
Type of Device
ELECTRODE, PH, STOMACH
Manufacturer (Section D)
GIVEN IMAGING LTD., YOQNEAM
yetsira 13 street
yoqneam 20692
MDR Report Key9712696
MDR Text Key179472382
Report Number9710107-2020-00073
Device Sequence Number1
Product Code FFT
UDI-Device Identifier07290101369714
UDI-Public07290101369714
Combination Product (y/n)N
PMA/PMN Number
K102543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 04/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/23/2021
Device Model NumberFGS-0636
Device Catalogue NumberFGS-0636
Device Lot Number47368F
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2020
Date Manufacturer Received03/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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