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 2016-10-13 for ETHB5LT manufactured by Sterilmed, Inc..
[57304701]
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 received.
Patient Sequence No: 1, Text Type: N, H10
[57304702]
It was reported that the tip of the trocar device broke off during the procedure. The patient and procedure were not affected as a result of the device failure. The tip did break off inside of the patient. All parts were recovered.
Patient Sequence No: 1, Text Type: D, B5
[60909232]
The device was returned to the manufacturer and subjected to inspection. The obturator had contaminants present and the tip of the obturator missing. The root cause for the damage is uncertain. The tip of the obturator may have been dislodged during use, or during handling/mishandling of the device in the field.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2016-00073 |
| MDR Report Key | 6026060 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-13 |
| Date of Report | 2016-09-14 |
| Date of Event | 2016-09-14 |
| Date Mfgr Received | 2016-11-08 |
| Date Added to Maude | 2016-10-13 |
| 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 | JASON ANDERSON |
| Manufacturer Street | 5010 CHESHIRE PARKWAY SUITE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634888348 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED |
| Product Code | NLM |
| Date Received | 2016-10-13 |
| Returned To Mfg | 2016-11-08 |
| Model Number | ETHB5LT |
| Catalog Number | ETHB5LT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-13 |