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

Model Number	FGS-0347
Medical Device Problem Codes	Loss of Power (1475); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, they had a short study which was suspected to be due to the recorder turning off.The patient returned the recorder with the study downloaded which was only 4 hours.They confirmed that the capsule did reach the colon but was concerned that the capsule may have "popped back out," so they performed an x ray, but did not have the results.There was no reported patient outcome.
Additional Manufacturer Narrative
Additional information: (serial#), evaluation summary: this report is based on information provided by medtronic investigation personnel.The device was received for evaluation.A review of the lot number reported indicates that this product was manufactured as non-sterile.Non-sterile product carries only a manufacturing date and not an expiration date.The returned sample did not meet specification as received by medtronic.The visual inspection found no notable conditions.The customer reported they had a short study which was suspected to be due to the recorder turning off.The reported condition was confirmed.The "power on" without "power off" before it uniquely indicates that the recorder was in the state of "hang-up", this was cause for the reported problem.Presumably the impact of static electricity (esd) has led to the hang up of the device and the reported problem of the customer.The investigation identified the cause of the reported event to be suspected esd.This issue has been addressed.A review of the dhr indicating that the product was released meeting finished product specifications.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, they had a short study which was suspected to be due to the recorder turning off.The patient returned the recorder with the study downloaded which was only 4 hours.They confirmed that the capsule did reach the colon but was concerned that the capsule may have "popped back out," so they performed an x ray, but did not have the results.After the study was reviewed, it was determined that there was only 04:14:14 of recording.It appeared that even though the study was "short," the capsule did pass through the small bowel and reached the cecum.It was also confirmed that the recorder malfunctioned during the study as it powered itself off several times and eventually at the very end of the study.There was no reported patient outcome.

• 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: 8235305
• Report Number: 9710107-2019-00019
• Device Sequence Number: 16197324
• Product Code: NEZ
• UDI-Device Identifier: 07290101362951
• UDI-Public: 07290101362951
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123864
• 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,Followup
• Report Date (Section B): 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FGS-0347
• Device Catalogue Number: FGS-0347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 03/19/2019; 04/16/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 04/11/2019; 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other