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 2020-03-19 for BRAVO FGS-0636 manufactured by Given Imaging Ltd., Yoqneam.
[184061218]
This product is 510(k) exempt. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184061219]
According to the reporter, they had a capsule which failed to detach. The customer used the backup technique and broke the handle in order to remove the deployment device, but it did not detach. They also used gentle pressure and multiple attempts to detach the device, but it was unsuccessful. There was no harm to the patient and the user and no repeat procedure was performed. There was nothing unusual about the patient or the procedure, and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal. No lubrication was used to facilitate placement of the capsule.
Patient Sequence No: 1, Text Type: D, B5
[188663837]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188663838]
According to the reporter, they had a capsule which failed to detach. The customer used the backup technique and broke the handle in order to remove the deployment device, but it did not detach. They also used gentle pressure and multiple attempts to detach the device, but it was unsuccessful. There was no harm to the patient and the user and no repeat procedure was performed. There was nothing unusual about the patient or the procedure, and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal. No lubrication was used to facilitate placement of the capsule.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2020-00138 |
| MDR Report Key | 9852884 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-19 |
| 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 | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| 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 | FFT |
| Date Received | 2020-03-19 |
| Model Number | FGS-0636 |
| Catalog Number | FGS-0636 |
| Lot Number | 48449F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-19 |