MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for BRAVO FGS-0313 manufactured by Given Imaging Ltd., Yoqneam.
[185899819]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185899820]
According to the reporter, during the release of the capsule, it did not drop and the handle broke in the operator's hands. They attempted to cut the sheath to perform the release despite the broken handle, but they still had the failure. The patient was prepped for the procedure and was under anesthesia, but there was no patient and there was no user harm. A second capsule was used for the same procedure on the same day. There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure. The delivery system and capsule will not be returned for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2020-00179 |
| MDR Report Key | 9905364 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-01-02 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 Country | IL |
| 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 | 2020-03-31 |
| Returned To Mfg | 2020-03-20 |
| Model Number | FGS-0313 |
| Catalog Number | FGS-0313 |
| Lot Number | 44062Q |
| Device Expiration Date | 2020-01-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LTD., YOQNEAM |
| Manufacturer Address | YETSIRA 13 STREET YOQNEAM 20692 IL 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |