MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-06-21 for ETHH12LP manufactured by Sterilmed, Inc..
[78085228]
The device has not yet been returned to the manufacturer at the time of this report. A supplemental form will be sent once the evaluation is completed if the device is returned. The device history report was not reviewed as no lot number was given. (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[78085229]
It was reported that a black circular part broke off of the device during the procedure. Additional information has been requested but additional information was not received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2017-00053 |
| MDR Report Key | 6657166 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-21 |
| Date of Report | 2017-05-23 |
| Date of Event | 2017-01-19 |
| Date Mfgr Received | 2017-05-23 |
| Date Added to Maude | 2017-06-21 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAY ANDERSON |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED |
| Product Code | NLM |
| Date Received | 2017-06-21 |
| Model Number | ETHH12LP |
| Catalog Number | ETHH12LP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE. MAPLE GROVE MN 55369 US 55369 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-21 |