MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-30 for HF-RESECTION ELECTRODE, 45? NEEDLE, 24-28 FR. A22255C manufactured by Olympus Winter & Ibe Gmbh.
[146642597]
The device was not returned to the service center for evaluation as the user facility discarded the device after the procedure; however, the staff was going see if the device could be retrieved. The cause of the reported event cannot be determined at this time. Based on similar device reports, the most probable cause of the reported broken hf electrode tip can be attributed to: physical damage, excessive output from the generator, and/or metal to metal contact with the hf electrode. The instruction manual warns users "warning! Read all instruction manuals thoroughly. Before use, read this manual, the olympus endoscopy system guide, and the manuals for all other equipment which will be used during the procedure. An insufficient understanding of the dangers, warnings, cautions and information in these manuals can result in death, serious injury or equipment damage. When attaching the electrode, make sure not to push it too forcefully into the working element. Otherwise the electrode may be damaged. " if the suspect medical devices are returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[146642598]
The service center was informed that during an unspecified procedure, the doctor observed that the sterile disposable electrode needle broke off and fell into the patient? S bladder. The doctor was able retrieve the metal device fragment. The intended procedure was completed. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00889 |
| MDR Report Key | 8654958 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-30 |
| Date of Report | 2019-07-19 |
| Date of Event | 2019-04-29 |
| Date Mfgr Received | 2019-05-24 |
| Date Added to Maude | 2019-05-30 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HF-RESECTION ELECTRODE, 45? NEEDLE, 24-28 FR. |
| Generic Name | HF-RESECTION ELECTRODE |
| Product Code | GCP |
| Date Received | 2019-05-30 |
| Model Number | A22255C |
| Catalog Number | A22255C |
| Lot Number | 160204PO2L001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG, HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-30 |