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, ROLLER, 24-28 FR A22251C manufactured by Olympus Winter & Ibe Gmbh.
[99989251]
The customer returned five of six electrodes to olympus for evaluation. A visual inspection of the third electrode (a22251c lot# p1780004) found a portion of the wire that holds the roller ball at the distal tip is broken and separated from the grey colored resection post. The roller ball is intact. A microscope inspection of the breakage point found the roller ball and the resection post are discolored. The insulation at the distal tip on both resection posts are charred, burned and melted. No part of the wire that holds the roller in place is suspected to be missing. The cause of the reported event could not be conclusively determined as the user facility did not return the concomitant devices for testing. However, based on similar reported events the most probable cause of the reported event could be attributed to the electrode coming 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 could cause the electrode to become damaged.
Patient Sequence No: 1, Text Type: N, H10
[99989252]
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. 3 of 6.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00085 |
| MDR Report Key | 7251856 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-02-08 |
| Date of Report | 2018-02-08 |
| Date of Event | 2018-01-12 |
| Date Mfgr Received | 2018-01-16 |
| Device Manufacturer Date | 2017-08-01 |
| 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, ROLLER, 24-28 FR |
| Generic Name | HF ELECTRODE |
| Product Code | GCP |
| Date Received | 2018-02-08 |
| Returned To Mfg | 2018-01-30 |
| Model Number | A22251C |
| Catalog Number | A22251C |
| Lot Number | P1780004 |
| ID Number | 14042761036815 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-02-08 |