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 2017-10-02 for BRAVO FGS-0312 manufactured by Given Imaging Ltd., Yoqneam.
[88239372]
Patient Sequence No: 1, Text Type: N, H10
[88239373]
According to the reporter, they had a bravo capsule which failed to detach. It was reported there was no harm caused to the patient, a repeat procedure was performed. There was nothing unusual about the patient or procedure and an endoscopy was performed prior to the bravo procedure and the esophagus appeared to be normal. The vacuum source was medela and the vacuum pressure before the procedure was 550 mmhg. Lubricant was used to facilitate placement of the capsule but it is not known if any lubricant got into the capsule chamber. The patient did not suffer from any adverse event during the procedure. The delivery system is expected be returned to given.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2017-05531 |
| MDR Report Key | 6907720 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-02 |
| Date of Report | 2017-09-26 |
| Date Mfgr Received | 2017-09-26 |
| Date Added to Maude | 2017-10-02 |
| 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 | 3 |
| Brand Name | BRAVO |
| Generic Name | CAMERA, STILL, SURGICAL |
| Product Code | FTT |
| Date Received | 2017-10-02 |
| Model Number | FGS-0312 |
| Catalog Number | FGS-0312 |
| Lot Number | 35301Q |
| Device Expiration Date | 2018-05-25 |
| 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 | 2017-10-02 |