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 2018-02-08 for HF-RESECTION ELECTRODE, LOOP, 26 FR A22202C manufactured by Olympus Winter & Ibe Gmbh.
[99992433]
The customer returned five of six electrodes to olympus for evaluation. The second electrode (a22202c, lot p1710002) was not returned to olympus for evaluation. The cause of the reported event could not be determined. However, based on the similar reported events related to the device, the most probable cause of the reported event can occur when mechanical overload by the application of excessive force and improper handling, the electrode comes into contact (unintended) with other metal parts, e. G. Surgical instruments while the high-frequency output was activated and higher output settings on the electrosurgical generator which could cause the loop wire of the electrode to become damaged.
Patient Sequence No: 1, Text Type: N, H10
[99992434]
Olympus was informed that during a transurethral resection of prostate (turp) procedure, the loop wire on two (a22202c) electrodes and the roller of four (a22251c) electrodes broke off inside of a patient. The device fragments were retrieved from the patient. The procedure was completed using an unspecified electrode. No patient injury was reported. Two of six.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00087 |
| MDR Report Key | 7251890 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-02-08 |
| Date of Report | 2018-03-01 |
| Date of Event | 2018-01-12 |
| Date Mfgr Received | 2018-02-09 |
| Device Manufacturer Date | 2017-01-02 |
| Date Added to Maude | 2018-02-08 |
| 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 | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HF-RESECTION ELECTRODE, LOOP, 26 FR |
| Generic Name | HF-RESECTION ELECTRODE |
| Product Code | GCP |
| Date Received | 2018-02-08 |
| Model Number | A22202C |
| Catalog Number | A22202C |
| Lot Number | P1710002 |
| ID Number | 14042761036662 |
| Operator | PHYSICIAN |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-08 |