MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-18 for SCALPEL, ULTRASONIC, REPROCESSED manufactured by Sterilmed, Inc..
[179743842]
The surgical team noticed white pad on the jaw of harmonic scalpel becoming dislodged on the video monitor. Instrument was taken out of the patient's abdomen and the white pad, then the white pad came off the device at that time outside the patient. A new device was opened, case resumed and finished.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9719888 |
| MDR Report Key | 9719888 |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-31 |
| Report Date | 2020-02-04 |
| Date Reported to FDA | 2020-02-04 |
| Date Reported to Mfgr | 2020-02-18 |
| Date Added to Maude | 2020-02-18 |
| 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 | RISK MANAGER |
| 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 |
| Generic Name | SCALPEL, ULTRASONIC, REPROCESSED |
| Product Code | NLQ |
| Date Received | 2020-02-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 5010 CHESHIRE PKWY N STE 2 PLYMOUTH MN 55446 US 55446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |