MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-12 for STORZ 40000 * manufactured by Storz Instrument Co.
[87761]
Technician investigated report of lack of vacuum and pressure in cabinet. Was last inspected 8/29/97. When turned on pressure pump, 2 1/2 inch diameter, plastic pressure vessel, schedule 30 pvc, pipe exploded under approximately 120 psi pressure. Possible that tubing was crimped. The end cap fragmented. According to company current production of this item uses a smaller stainless steel pressure vessel. Plan is to replace these parts on other cabinets.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013016 |
| MDR Report Key | 149946 |
| Date Received | 1998-02-12 |
| Date of Report | 1998-02-11 |
| Date of Event | 1998-01-06 |
| Date Added to Maude | 1998-02-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ |
| Generic Name | ENT CABINET |
| Product Code | ETF |
| Date Received | 1998-02-12 |
| Model Number | 40000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 146111 |
| Manufacturer | STORZ INSTRUMENT CO |
| Manufacturer Address | 3365 TREE CT INDUSTRIAL BLVD ST LOUIS MO 63122 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-02-12 |