MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 1999-07-02 for BAKES BILE DUCT DILATOR 3MM EB063R manufactured by Aesculap Ag & Co. Kg.
[18327259]
Exact surgical procedure unknown, however, an aesculap dilator was being used when the distal tip fractured and lodged in biliary duct. Retrieval of fractured tip was unsuccessful and event prolonged surgery time. Pt is being monitored by surgeon on outpatient basis and no complications have been reported. This event type is occurring below the frequency and severity that are usual for this device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-1999-00015 |
| MDR Report Key | 230065 |
| Report Source | 06,07 |
| Date Received | 1999-07-02 |
| Date of Report | 1999-07-02 |
| Date of Event | 1999-05-26 |
| Date Mfgr Received | 1999-06-10 |
| Date Added to Maude | 1999-07-07 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAKES BILE DUCT DILATOR 3MM |
| Generic Name | DILATOR |
| Product Code | EZM |
| Date Received | 1999-07-02 |
| Model Number | NA |
| Catalog Number | EB063R |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 223126 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN GM 78501 |
| Baseline Brand Name | BAKES BILE DUCT DILATOR 3MM |
| Baseline Generic Name | DILATOR |
| Baseline Model No | NA |
| Baseline Catalog No | EB063R |
| Baseline ID | NA |
| Baseline Device Family | DILATORS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 1999-07-02 |