MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-12-24 for DISPOSABLE BIOPSY FORCEPS FB-230K manufactured by Olympus Medical Systems Corp..
[185599135]
The subject device referenced in this report was not returned to olympus for evaluation. Therefore the exact cause of the reported event could not be conclusively determined at this time. A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Patient Sequence No: 1, Text Type: N, H10
[185599136]
During a gastric biopsy, the subject device was used. In the antrum biopsy, a tissue was torn and a large sample was taken with the subject device. In the fundic biopsy, a tissue was torn and a large sample was taken with the subject device. As a result, severe bleeding occurred. Clips were used for treatment of two biopsy sites. The patient felt pain in the stomach. No visible complication was found in the scan conducted the next day. There was no prolonged hospitalization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-04587 |
| MDR Report Key | 9514586 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-12-24 |
| Date of Report | 2020-03-02 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-05-31 |
| Date Added to Maude | 2019-12-24 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE BIOPSY FORCEPS |
| Generic Name | DISPOSABLE BIOPSY FORCEPS |
| Product Code | FCL |
| Date Received | 2019-12-24 |
| Returned To Mfg | 2020-02-04 |
| Model Number | FB-230K |
| Lot Number | 95V |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-12-24 |