MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-06-24 for OLYMPUS 7028717 * manufactured by Keymed (medical & Industrial Equipment) Ltd..
[18602733]
The product is a guide wire used during endoscopic per-oral dilatation of tumors in the esophagus. It has a flexible coiled spring tip that became detached from the main portion of the wire during a procedure. The pt required an esophagectomy to repair a 2cm tear in the lower esophagus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2003-00001 |
| MDR Report Key | 470119 |
| Report Source | 06 |
| Date Received | 2003-06-24 |
| Date of Report | 2003-06-21 |
| Date of Event | 2001-05-21 |
| Date Mfgr Received | 2001-05-22 |
| Date Added to Maude | 2003-07-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MR R GRAY |
| Manufacturer Street | STOCK RD, SOUTHEND-ON-SEA |
| Manufacturer City | ESSEX SS2 5QH |
| Manufacturer Country | UK |
| Manufacturer Postal | SS2 5QH |
| Manufacturer Phone | 702616333 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | ESOPHAGEAL GUIDE WIRE |
| Product Code | EZM |
| Date Received | 2003-06-24 |
| Returned To Mfg | 2001-09-27 |
| Model Number | 7028717 |
| Catalog Number | * |
| Lot Number | 110641 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 458966 |
| Manufacturer | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD. |
| Manufacturer Address | STOCK RD, SOUTHEND-ON-SEA ESSEX UK SS2 5QH |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | ESOPHAGEAL GUIDE WIRE |
| Baseline Model No | 7028717 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-06-24 |