MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-07-12 for DISPOSABLE BIOPSY FORCEPS FB-220U manufactured by Olympus Medical Systems Corp..
[150860936]
The device was not returned to the service center for evaluation. The exact cause of the reported event cannot be determined at this time. The instruction manual provides the user several warnings in the? Collection of tissue? Section to mitigate patient injury or bleeding. Do not force the distal end of the insertion portion against body cavity tissue. Doing so could cause patient injury, such as perforation, bleeding, or mucous membrane damage. If you press the instrument? S distal end too hard against the tissue in an attempt to take a sample more than needed, the risk of perforation increase. Do not take more than needed. Biopsy may cause bleeding. If you take a large sample or press the instrument? S distal end against tissue excessively, the risk of bleeding will increase. Perform biopsy on minimum necessary spots only.
Patient Sequence No: 1, Text Type: N, H10
[150860937]
The service center was informed that during a diagnostic esophagogastroduodenoscopy (egd) procedure, while obtaining a biopsy the patient experienced a lot of bleeding and developed a hematoma. The bleeding was treated with two clips. It is unknown if the intended procedure was completed. (refer to report 1 of 2). Additionally, the user facility reported that this phenomenon has occurred with multiple physicians. This is report 2 of 2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2019-02530 |
| MDR Report Key | 8785689 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-07-12 |
| Date of Report | 2019-10-08 |
| Date of Event | 2019-06-15 |
| Date Mfgr Received | 2019-09-16 |
| Date Added to Maude | 2019-07-12 |
| 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 | 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 | 2019-07-12 |
| Returned To Mfg | 2019-09-13 |
| Model Number | FB-220U |
| Lot Number | N5355430 |
| 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. Required No Informationntervention | 2019-07-12 |