MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 1999-09-30 for VARI-STAT VARIABLE LOW TEMP CAUTERY 84-40000 manufactured by Xomed Surgical Products, Inc..
[135754]
It was reported by the user facility, "the cautery was used to mark the location of a tear on the sclerotic in a detachment of the retina. It did not function as usual. At the same level on the rheostat, it overheated which lead to the incident. The outcome of the incident was a perforation of the sclerotic of the chroid and leaking of the vitreous body. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-1999-00009 |
| MDR Report Key | 242799 |
| Report Source | 01,05 |
| Date Received | 1999-09-30 |
| Date of Report | 1999-08-31 |
| Date of Event | 1999-01-01 |
| Date Mfgr Received | 1999-08-31 |
| Device Manufacturer Date | 1999-03-01 |
| Date Added to Maude | 1999-10-05 |
| 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 | MARK HIMES |
| Manufacturer Street | 6743 SOUTHPOINT DR NORTH |
| Manufacturer City | JACHSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797578 |
| Manufacturer G1 | XOMED SURGICAL PRODUCTS, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VARI-STAT VARIABLE LOW TEMP CAUTERY |
| Generic Name | CAUTERY |
| Product Code | HQP |
| Date Received | 1999-09-30 |
| Model Number | NA |
| Catalog Number | 84-40000 |
| Lot Number | 17838700 |
| ID Number | NA |
| Device Expiration Date | 2003-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 235227 |
| Manufacturer | XOMED SURGICAL PRODUCTS, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR. NORTH JACKSONVILLE FL 32216 US |
| Baseline Brand Name | VARI-STAT VARIABLE LOW TEMP CAUTERY |
| Baseline Generic Name | CAUTERY |
| Baseline Model No | NA |
| Baseline Catalog No | 84-40000 |
| Baseline ID | NA |
| Baseline Device Family | CAUTERY |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 48 |
| 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. Required No Informationntervention | 1999-09-30 |