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 2017-09-19 for BRAVO FGS-0312 manufactured by Given Imaging Ltd., Yoqneam.
[86641515]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[86641516]
According to the reporter, a bravo capsule failed to attach during the procedure. There was no harm to the patient or user and a repeat procedure was necessary due to the alleged device malfunction. The equipment and capsule is expected to be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[109586796]
Device evaluation: one bravo ph capsule delivery device and one capsule were received for investigation. The capsule was not attached to the delivery device. 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. A review of the device history record was performed and indicates that the product was released meeting finished product specifications. We were unable to confirm the customer? S report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710107-2017-05497 |
| MDR Report Key | 6876759 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-19 |
| Date of Report | 2018-05-25 |
| Date of Event | 2017-08-19 |
| Date Mfgr Received | 2018-04-25 |
| Device Manufacturer Date | 2016-12-12 |
| Date Added to Maude | 2017-09-19 |
| 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 | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| 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 | BRAVO |
| Generic Name | ELECTRODE, PH, STOMACH |
| Product Code | FTT |
| Date Received | 2017-09-19 |
| Returned To Mfg | 2018-04-08 |
| Model Number | FGS-0312 |
| Catalog Number | FGS-0312 |
| Lot Number | 33467Q |
| Device Expiration Date | 2017-12-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-09-19 |