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..
[185573934]
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
[185573935]
During a gastric fundic biopsy, the subject device was used. The tissue was torn and a large sample was taken off. As a result, significant bleeding occurred. Clips were used for hemostasis. The intended procedure was completed with another device. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-04588 |
| MDR Report Key | 9514585 |
| 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 | 2019-12-24 |