MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-07 for PILLCAM FGS-0155 manufactured by Given Imaging, Inc..
[119500363]
A pillcam capsule endoscopy was planned. The first pillcam we used had difficulty syncing with the capsule data collecting device, so a second pillcam was then obtained. This second pillcam synced with the device, and an upper endoscopy was done to place the pillcam. The next day, after the capsule data was reviewed, it was discovered that the data collection was incomplete. There were large sections where recording appears to be missing starting at about 2 hr and 45 mins into the study. Then the recording resumes for about 3 mins at 3 hr 12 mins and then stops recording again at 3 hr 15 mins. The capsule stops recording altogether at about 3 hr 45 mins.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7854718 |
| MDR Report Key | 7854718 |
| Date Received | 2018-09-07 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-08-22 |
| Report Date | 2018-08-29 |
| Date Reported to FDA | 2018-08-29 |
| Date Reported to Mfgr | 2018-09-07 |
| Date Added to Maude | 2018-09-07 |
| 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, ESOPHAGEAL, WIRELESS, CAPSULE |
| Product Code | NSI |
| Date Received | 2018-09-07 |
| Model Number | FGS-0155 |
| Catalog Number | FGS-0155 |
| Lot Number | 40764S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING, INC. |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-07 |