MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2001-05-21 for OLYMPUS 55391A 7002718 manufactured by Keymed (medical & Industrial Equipment), Ltd..
[221869]
Reported that the flexible tip from an esophageal guide wire became detached during an esophageal dilatation at the memorial medical center, port lavaca tx, and the remaining wire perforated the patient's duodenum. The pt was referred to another hospital for surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2001-00001 |
| MDR Report Key | 336004 |
| Report Source | 08 |
| Date Received | 2001-05-21 |
| Date of Report | 2001-05-21 |
| Date of Event | 2001-03-08 |
| Date Mfgr Received | 2001-03-19 |
| Device Manufacturer Date | 2000-08-01 |
| Date Added to Maude | 2001-06-07 |
| 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, HEAD OF QA/RA |
| Manufacturer Street | STOCK ROAD |
| Manufacturer City | SOUTHEND-ON-SEA, 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 | 2 METRE ESOPHAGEAL GUIDE WIRE |
| Product Code | EZM |
| Date Received | 2001-05-21 |
| Model Number | 55391A |
| Catalog Number | 7002718 |
| Lot Number | 138175 (SUSPECTED) |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 325329 |
| Manufacturer | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. |
| Manufacturer Address | STOCK ROAD SOUTHEND-ON-SEA, ESSEX UK SS2 5QH |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | 2 METRE ESOPHAGEAL GUIDE WIRE |
| Baseline Model No | 55391A |
| Baseline Catalog No | 7002718 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2001-05-21 |