MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2006-12-06 for OLYMPUS FB-220U * manufactured by Olympus Optical Co. Ltd..
[18489149]
The hosp reported that this serrated jaw forcep is taking a larger biopsy sample than the customer desires when collecting sample tissue. The customer further reports that this forcep tears mucosal samples, rather than cleanly bites samples from the mucosal wall. In addition, the customer has observed a hematoma forming as the forcep is collecting tissue.
Patient Sequence No: 1, Text Type: D, B5
[18726535]
The device in question was not returned to olympus for investigation. The forcep has been discarded following the procedure. The hosp reported that one pt was admitted to the hosp due to the tear on the mucosal wall noted during the exploration of the colon. The pt as seen in the emergency room, but no surgery was performed, since there was no excessive bleeding that occurred. The cause of the user's experience cannot be determined. This report is being reported as an mdr in an excess of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2006-00119 |
| MDR Report Key | 795434 |
| Report Source | 00,05,06 |
| Date Received | 2006-12-06 |
| Date of Report | 2006-11-14 |
| Date Added to Maude | 2006-12-19 |
| 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 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS OPTICAL CO. LTD. |
| Manufacturer Street | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1-CHOME |
| Manufacturer City | TOKYO 163-91 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 163-91 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | BIOPSY FORCEPS |
| Product Code | BWH |
| Date Received | 2006-12-06 |
| Model Number | FB-220U |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 783018 |
| Manufacturer | OLYMPUS OPTICAL CO. LTD. |
| Manufacturer Address | SHINJUKU-KU 1-CHOME TOKYO * |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | BIOPSY FORCEPS |
| Baseline Model No | FB-220U |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-12-06 |