MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for PILLCAM FGS-0590 manufactured by Given Imaging.
[185024667]
Capsule was uploaded and paired correctly during case. In recovery, when we checked the capsule it was found it stopped working and recording. Doctor notified. Removed recorder and belt from patient. Belt shorted out and would not pair again with the recorder. Belt removed from service. Another capsule will be deployed later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9882504 |
| MDR Report Key | 9882504 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-13 |
| Report Date | 2020-03-13 |
| Date Reported to FDA | 2020-03-13 |
| Date Reported to Mfgr | 2020-03-26 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLCAM |
| Generic Name | SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE |
| Product Code | NEZ |
| Date Received | 2020-03-26 |
| Model Number | FGS-0590 |
| Catalog Number | FGS-0590 |
| Lot Number | 46491SA#095 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |