MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM PILLCAM; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Model Number	FGS-0347-J
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2019
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, there was a short video as only the image of the esophagus was taken.The recording only lasted for about 3 minutes, so it was necessary to perform a repeat procedure and another capsule was used for this.There was no user or patient harm.
Additional Manufacturer Narrative
This event has been reassessed and the reportability has been determined to be a non reportable malfunction.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: the product sample was not returned to the medtronic laboratory; however, a data files was provided by the customer for analysis.The customer reported there was a short video as only the image of the esophagus was taken.The reported condition was confirmed.The investigation found: the gfh and log files were reviewed found that the capsule stopped transmit data during procedure for unknown reason, this was led to the reported problem.The investigation found the most probable cause to be the product doesn't transmit component.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PILLCAM
• Common Device Name: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 9167876
• Report Number: 9710107-2019-00448
• Device Sequence Number: 19506267
• Product Code: NEZ
• UDI-Device Identifier: 07290101362951
• UDI-Public: 07290101362951
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2019

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: FGS-0347-J
• Device Catalogue Number: FGS-0347-J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/29/2019; 10/29/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/12/2019; 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1