MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 1996-09-06 for STORZ DAVIS MOUTH GAG N7451 manufactured by Storz Instrument Company.
[20685219]
During a tonsillectomy procedure, the mechanism that controls the lock on this mouth gag was not working correctly and a crack could be seen. Another gag was used to successfully complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932180-1996-00071 |
| MDR Report Key | 40658 |
| Report Source | 00,06 |
| Date Received | 1996-09-06 |
| Date of Report | 1996-08-08 |
| Report Date | 1996-08-08 |
| Date Reported to Mfgr | 1996-08-08 |
| Date Mfgr Received | 1996-08-08 |
| Date Added to Maude | 1996-10-04 |
| 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 DAVIS MOUTH GAG |
| Generic Name | MOUTH GAG |
| Product Code | KBN |
| Date Received | 1996-09-06 |
| Model Number | NA |
| Catalog Number | N7451 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 41748 |
| Manufacturer | STORZ INSTRUMENT COMPANY |
| Manufacturer Address | 3365 TREE COURT INDUSTRIAL BLVD ST LOUIS MO 63122 US |
| Baseline Brand Name | STORZ DAVIS DOUBLE BITE MOUTH GAG |
| Baseline Generic Name | MOUTH GAG |
| Baseline Model No | NA |
| Baseline Catalog No | N7451 |
| Baseline ID | NA |
| Baseline Device Family | MOUTH GAG |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-09-06 |