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

Model Number FGS-0636

Device Problems Loss of or Failure to Bond (1068); Positioning Failure (1158); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter while the physician was in the process of placing the capsule, they noticed that the tip of the delivery system was bent.They used a second capsule and was successful.There was no patient or user harm.

Manufacturer Narrative

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

Event Description

According to the reporter, while the physician was in the process of placing the capsule, they noticed that the tip of the delivery system was bent.It was not noticed before it was passed down the esophagus.They used a second capsule on the same day and was successful.There was no patient or 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 bravo device arriving in bio lab.One bravo device (capsule and delivery) was received for evaluation.Since inadequate sample was returned for investigation it is impossible to determine if product meet specs or not.An investigation of the returned equipment was not performed since the sample was sent as bio-hazard contaminated to the lab and is not a bio-hazard device.Evaluation was not performed since the product sample did not arrive for investigation in a proper manner allowing investigation.The investigation could not determine a cause or a probable root cause for the customer's report based on the information provided and sample received.The bio-hazard procedure states: it is forbidden to open contaminated returned equipment outside bio lab (p.4 section 8).All parts transferred to the biohazard lab will be considered as contaminated.(p.5 section 9).A review of the device history records indicated that this serial 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: 9902177
• MDR Text Key: 185658054
• Report Number: 9710107-2020-00172
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369714
• UDI-Public: 07290101369714
• 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: 05/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: FGS-0636
• Device Catalogue Number: FGS-0636
• Device Lot Number: 47783F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1