MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-10-01 for PILLCAM FGS-0109 manufactured by Given Imaging Ltd., Yoqneam.
[122215351]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[122215352]
According to the reporter, the recorder stopped working an hour after the start of the procedure. Technical support had the customer check in patient on the second recorder and to place the first recorder in front of the patient name at check in so it does not delete the first video. The customer informed that the record did not flashed yellow led. Technical support provided the steps on how to copy the raw data and once done, to check on a patient on the same recorder. The customer successfully copied the raw data and checked in patients. They informed that the patient spit out the capsule case and just the outer layer of the capsule and also confirmed patient reporting of sore throat or pain, and then the patient felt comfort when they spit out the capsule, but the same thing happened approximately an hour and a half after when the patient ingested the patency capsule the day before the procedure. The customer reached out and stated that a physician advised them to have the patient swallow the same patency capsule and at midnight an x-ray was done to check the patency capsule, but there was no trace. The patient then swallowed the capsule the day after, then initially, the blue light was flashing and then after one and a half hours later, the blue light stopped flashing. The patient then had minor pain and a bitter taste and spit out the patency capsule, which was intact with slight disintegration noted, and then the pain and bitter taste went away completely. Then the patient coughed up the capsule approximately 30-45 minutes after while it was still taking pictures and not transmitting them, and the customer confirmed the capsule was intact. The study will be sent in for review. The customer and technical support, troubleshoot the issue with the recorder and tried to resume the recording and the patient reported spitting out the capsule in pieces. Tech support then confirmed the capsule did not show a camera head, which suggested the capsule broke apart in the patient's body, so the customer spoke with the doctor to order an x-ray for confirmation. The patient had no other complaints.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2018-00967 |
| MDR Report Key | 7923288 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-01 |
| Date of Report | 2018-10-01 |
| Date Mfgr Received | 2018-08-15 |
| Date Added to Maude | 2018-10-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | GIVEN IMAGING LTD., YOQNEAM |
| Manufacturer Street | YETSIRA 13 STREET |
| Manufacturer City | YOQNEAM 20692 |
| Manufacturer Postal Code | 20692 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLCAM |
| Generic Name | SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE |
| Product Code | NSI |
| Date Received | 2018-10-01 |
| Model Number | FGS-0109 |
| Catalog Number | FGS-0109 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LTD., YOQNEAM |
| Manufacturer Address | YETSIRA 13 STREET YOQNEAM 20692 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-01 |