MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-02-13 for LAPAROSCOPIC SMOKE EVAC TUBING SET 60-6810-001 manufactured by Buffalo Filter.
[183307262]
At time of filing, although expected, the reported device has not been returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[183307263]
During incoming inspection, the distributor rejected this device, catalog # 60-6810-001, laparoscopic smoke evac tubing set , lot 140843, for a possible insufficient heatseal. There was no contact with the patient as this was found during incoming inspection. Due to the potential severity of a breach in sterility, this report is being raised as a malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2020-00068 |
| MDR Report Key | 9706035 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-02-13 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-02-13 |
| 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 | MS TRACEY WEISELBENTON |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO, FL |
| Manufacturer Country | US |
| Manufacturer Phone | 3995557 |
| Manufacturer G1 | BUFFALO FILTER |
| Manufacturer Street | 8388 BRIDLEWOOD DRIVE |
| Manufacturer City | E. AMHERST, NY |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAPAROSCOPIC SMOKE EVAC TUBING SET |
| Generic Name | APPARATUS, EXHAUST, SURGICAL |
| Product Code | FYD |
| Date Received | 2020-02-13 |
| Catalog Number | 60-6810-001 |
| Lot Number | 140843 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BUFFALO FILTER |
| Manufacturer Address | 8388 BRIDLEWOOD DRIVE E. AMHERST, NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-13 |