MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-06 for BRAVO FGS-0312 manufactured by Given Imaging Ltd., Yoqneam.
[85120058]
Patient Sequence No: 1, Text Type: N, H10
[85120059]
According to the reporter the customer had a bravo capsule which failed to attach, no harm was caused to the patient and a repeat procedure was performed. It was reported no intervention was necessary to correct an injury and nothing unusual about the patient or the procedure which led to the incident. Prior to the procedure an endoscopy was performed and the esophagus appeared to be normal. The physician has been performing the bravo procedure for many years, and was trained by a given representative. It is unknown what the vacuum source was or the pressure before the procedure. The physician is not clear to what caused the failure to attach, they felt that everything went well during the process, but then it felt like it was stuck after the deployment. The device is expected to be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[109144472]
Investigation summary: it was reported that one bravo ph capsule failed to attach to the patient esophagus. One bravo ph capsule delivery device was received for investigation. The capsule was not attached to the delivery device. The capsule was received for investigation. Visual inspection did not reveal any damage, and appears to have functioned within specification. Functional testing could not be performed because this is a single use device and once the capsule is delivered it cannot be functionally tested. Investigation conclusion for the failure to attach could not be reliably determined. Additionally, a review of the device history record was performed and indicates that the product was released meeting finished product specifications. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710107-2017-05466 |
| MDR Report Key | 6844331 |
| Date Received | 2017-09-06 |
| Date of Report | 2017-08-28 |
| Date of Event | 2017-08-28 |
| Date Mfgr Received | 2017-10-01 |
| Device Manufacturer Date | 2017-05-09 |
| Date Added to Maude | 2017-09-06 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925297 |
| 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 | 0 |
| Brand Name | BRAVO |
| Generic Name | CAMERA, STILL, SURGICAL |
| Product Code | FTT |
| Date Received | 2017-09-06 |
| Model Number | FGS-0312 |
| Catalog Number | FGS-0312 |
| Lot Number | 35290Q |
| Device Expiration Date | 2018-05-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-09-06 |