MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-01-22 for OLYMPUS DISPOSABLE BIOPSY FORCEPS FB-221D manufactured by Olympus Medical System Corp..
[4551291]
Olympus was informed that during four to six therapeutic bronchoscopy procedures, plastic shavings were noted in the patient's lungs. The shavings were thin and approximately 5mm. The shavings were retrieved with forceps or suction. The user did feel some resistance when inserting the forceps into the biopsy channel. There was no patient injury reported. Olympus followed up with the user facility to obtain additional information regarding the report and was informed that the shavings were attributed to the needle of the forceps not retracting when the forceps were closed. The exposed needle shaved the inside of the biopsy channel during deployment.
Patient Sequence No: 1, Text Type: D, B5
[11833546]
An olympus representative visited the user facility to inspect the forceps and noted that the needle was bent outward. The forceps will be returned to olympus for further investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00018 |
| MDR Report Key | 3747820 |
| Report Source | 06 |
| Date Received | 2014-01-22 |
| Date of Report | 2014-01-06 |
| Date of Event | 2013-12-27 |
| Date Mfgr Received | 2014-01-06 |
| Date Added to Maude | 2014-05-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEM CORP. |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS DISPOSABLE BIOPSY FORCEPS |
| Generic Name | DISPOSABLE BIOPSY FORCEPS |
| Product Code | HFB |
| Date Received | 2014-01-22 |
| Model Number | FB-221D |
| Catalog Number | FB-221D |
| Lot Number | 38T |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEM CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-22 |