MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for SONICISION COVSCD396 manufactured by Sterilmed, Inc..
[184889045]
Upon placing battery there was a delay with the green indicator light. Doctor complained of the jaws sticking and not opening. New battery was tried first then another device was opened and worked fine. Manufacturer response for sonicision, sonicision (per site reporter). There has not been a response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9876904 |
| MDR Report Key | 9876904 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-24 |
| Date of Event | 2019-10-22 |
| Report Date | 2020-02-24 |
| Date Reported to FDA | 2020-02-24 |
| Date Reported to Mfgr | 2020-03-25 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SONICISION |
| Generic Name | SCALPEL, ULTRASONIC, REPROCESSED |
| Product Code | NLQ |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2019-10-25 |
| Model Number | COVSCD396 |
| Catalog Number | COVSCD396 |
| Lot Number | 92310263X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 5010 CHESHIRE PARKWAY N SUITE 2 PLYMOUTH MN 55446 US 55446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |