MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; CAMERA, STILL, SURGICAL

Model Number	RFB-0450
Medical Device Problem Codes	Loss of Power (1475); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, ten and a half hours after capsule placement, the recorder displayed error code ¿386err_j2c024/driver¿ and it turned off.The customer press and hold power button for 30 seconds, but there was no response.The customer then pressed circle, triangle, square and circle buttons, but there was no change in error state.A repeat procedure will be performed.The customer noted that the recorder worked correctly during previous procedure.There was no patient injury.The device will be returned for data extraction.
Additional Manufacturer Narrative
Additional information: evaluation summary: this report is based on information provided by medtronic investigation personnel.The bravo recorder was received for evaluation.The returned sample met specification as received by medtronic.The visual inspection found no issues.The customer reported that ten and half hours after capsule placement, the recorder displayed error code ¿386err_j2c024/driver¿.The reported condition was not confirmed.The investigation found the device to function normally and within specifications.The investigation could not determine a cause or a probable root cause for the customer's report based on the information provided.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, ten and half hours after capsule placement, the recorder displayed error code ¿386err_j2c024/driver¿ and it turned off.The customer press and hold power button for 30 seconds, but there was no response.The customer then pressed circle, triangle, square and circle buttons, but there was no change in error state.A repeat procedure will be performed.The customer noted that the recorder worked correctly during previous procedure.There was no patient harm.The device will be returned for data extraction.Technical support received, disassembled and tested the recorder broke down when they were attempting to extract information.After many attempts data was downloaded via software version 6.

• Brand Name: BRAVO
• Common Device Name: CAMERA, STILL, SURGICAL
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 8283911
• Report Number: 9710107-2019-00040
• Device Sequence Number: 1617159
• Product Code: FTT
• UDI-Device Identifier: 07290101365303
• UDI-Public: 7290101365303
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K102543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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
• Operator of Device: Health Professional
• Device Model Number: RFB-0450
• Device Catalogue Number: RFB-0450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 02/10/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR