MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for SCISSORS "HIQ+", 5 X 330 MM, MINI-METZENBAUM, ERGO A63840A manufactured by Olympus Winter & Ibe Gmbh.
[139442672]
Olympus followed up with the user facility via telephone and in writing to obtain additional regarding the patient, procedure and the concomitant devices that were used but no additional information was provided. The referenced device was not returned to olympus. The cause of the reported event could not be confirmed. However, if additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[139442673]
Olympus was informed that during an unspecified procedure the tip of the device melted off and fell inside the patient. The tip then fused with the patient. The staff brought in a surgeon to surgically remove the melted piece from the patient. It was also reported that the doctor had the electrosurgical generator turned to 100 watts for an hour. The patient outcome is unknown and it is unknown whether the melted piece was retrieved from the patient or not.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00532 |
| MDR Report Key | 8417754 |
| Date Received | 2019-03-13 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-02-20 |
| Date Mfgr Received | 2019-02-20 |
| Date Added to Maude | 2019-03-13 |
| 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 | 0 |
| Brand Name | SCISSORS "HIQ+", 5 X 330 MM, MINI-METZENBAUM, ERGO |
| Generic Name | SCISSORS "HIQ+" |
| Product Code | HET |
| Date Received | 2019-03-13 |
| Model Number | A63840A |
| Catalog Number | A63840A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 1. Required No Informationntervention | 2019-03-13 |