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

Model Number	FGS-0109
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Abdominal Pain (1685); Radiation Exposure, Unintended (3164)
Date of Event	10/10/2018
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, the patency capsule was retained.When the capsule was given the customer returned a month after and complained of abdominal pain.They carried out an x-ray and computed tomography scan (ct-scan) which showed capsule was still in site, they carried out another x-ray and it showed the same thing that the capsule was intact in the site.
Additional Manufacturer Narrative
This report is based on information provided by medtronic investigation personnel.The product sample was not returned to the medtronic laboratory; however, an x-ray was provided by the customer for analysis.A review of the product expiration date discovered this product was used before the expiration date.The sample did not meet specification as received by medtronic.The x-ray show retention of patency capsule.The reported condition was confirmed.The investigation identified the root cause of the reported event to be physiological problem.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patency capsule was retained.When the capsule was given the customer returned a month after and complained of abdominal pain.They carried out an x-ray and ct scan which showed capsule was still in site, they carried out another x-ray and it showed the same thing that the capsule was intact in the site.The capsule was extracted by the patient after 8 days with no necessary medical intervention.
Additional Manufacturer Narrative
It was reported that the patency capsule was retained.The product sample was not returned to the laboratory; however, an x-ray was provided by the customer for analysis.The reported condition was confirmed.The investigation identified the root cause of the reported event to be physiological problem.A review of device history records indicated that the product released meeting all specifications as manufactured.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patency capsule was retained.The patient has a history of crohn¿s disease and had some abdominal pain before the test.A day after the capsule was given, the patient returned and complained of abdominal pain.The patient was admitted, and an x-ray and ct scan were performed which showed that the patency capsule was still in the small bowel.The patient had another x-ray 5 days post ingestion and the capsule was still seen and intact.The capsule was excreted 8 days after the capsule ingestion without a need for medical intervention.

• Brand Name: PILLCAM
• Common Device Name: SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 8051272
• Report Number: 9710107-2018-01039
• Device Sequence Number: 1807424
• Product Code: NSI
• UDI-Device Identifier: 07290101360629
• UDI-Public: 7290101360629
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K090557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2019

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-0109
• Device Catalogue Number: FGS-0109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 11/27/2018; 01/13/2019
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 12/20/2018; 02/06/2019
• 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: Required Intervention