MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-01-14 for STORZ ENT CABINET SMR40000 manufactured by Storz Instrument Co..
[17806612]
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
[21797548]
The dampner and hose attachment were received on 02/24/1998. There was a visible kink in the hose near the fitting that is threaded into the dampner. It is possible that the hose fitting may have been over-torqued to remove the kink which may have stresssed or weakened the cap. The inspection record for this cabinet indicates an inspection date of 11/06/1994 and that it had been sold to a customer in san antonio, tx. There are no requests for service on this cabinet.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1920664-1998-00024 |
| MDR Report Key | 144092 |
| Report Source | 05,06 |
| Date Received | 1998-01-14 |
| Date of Report | 1998-01-06 |
| Date of Event | 1998-01-05 |
| Date Facility Aware | 1998-01-05 |
| Report Date | 1998-01-06 |
| Date Reported to Mfgr | 1998-01-06 |
| Date Mfgr Received | 1998-01-06 |
| Date Added to Maude | 1998-01-16 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ ENT CABINET |
| Generic Name | ENT CABINET |
| Product Code | ETF |
| Date Received | 1998-01-14 |
| Model Number | NA |
| Catalog Number | SMR40000 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 140518 |
| Manufacturer | STORZ INSTRUMENT CO. |
| Manufacturer Address | 3365 TREE CT. INDUSTRIAL BLVD. ST. LOUIS MO 63122 US |
| Baseline Brand Name | ENT CABINET |
| Baseline Generic Name | ENT TREATMENT CABINET |
| Baseline Model No | NA |
| Baseline Catalog No | SMR40000 |
| Baseline ID | NA |
| Baseline Device Family | ENT CABINET |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-01-14 |