MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-04-17 for SLS LASER MD50 * manufactured by Specialty Surgical Instrumentation, Inc..
[133655]
Med record reviewed on 4-16-98. Pt with diagnosis of pelvic pain and problems recurrent endometriosis. Outpatient surgery on 4-7-98; diagnostic laparoscopy with video and laser vaporization of adhesions. During procedure, laser beam defocused, not pinpoint, when attempted to use in abdomen. Pretest beam focused and was pinpoint. Laser and scope to biomedical engineering for further eval of problem. No injury to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013620 |
| MDR Report Key | 164411 |
| Date Received | 1998-04-17 |
| Date of Report | 1998-04-16 |
| Date of Event | 1998-04-07 |
| Date Added to Maude | 1998-04-28 |
| 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 |
| 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 | SLS LASER |
| Generic Name | CARBON DIOXIDE LASER |
| Product Code | HHR |
| Date Received | 1998-04-17 |
| Model Number | MD50 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 160034 |
| Manufacturer | SPECIALTY SURGICAL INSTRUMENTATION, INC. |
| Manufacturer Address | 200 RIVER HILLS DR. NASHVILLE TN 37210 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-04-17 |