MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2016-01-27 for MID LABS 2405CE manufactured by Medical Instrument Development Laboratories, Inc..
[37242350]
At this time the device has not been returned to midlabs for investigation. Midlabs has made attempts to obtain the device from the customer. If/when the device is received an investigation will be performed, and midlabs will include the results in a follow-up medwatch report.
Patient Sequence No: 1, Text Type: N, H10
[37242351]
User facility reported that physician stated that during vitrectomy for intraocular foreign body the cutter stopped working after the first case. Facility did not know date of event, nor the lot number for the device. The device description is 20g, sp, vc (model 2405ce, lot # unk). This is an extended cutter. Procedure was completed and there was no patient injury reported. No delay in treatment, no medical intervention was required. The incident was reported to midlabs on (b)(6) 2015. To date, the device has not been returned to midlabs for investigation.
Patient Sequence No: 1, Text Type: D, B5
[53689207]
Upon receipt of product at midlabs (20 gauge, sp vitreous cutter - model 2405ce, lot # not reported) with the complaint "cutter stopped working", the device was examined and no abnormalities were observed. Examination showed that epoxy applied between cap and needle was intact. The following tests were conducted: aspiration test: result - pass 150 mmhg test on tester, normal flow observed. Tissue cut test: result - pass 60/600 cpm tissue cut tests. Retraction test: result - pass. Leak test: result - pass 50 psi open port and closed port leak tests. Device passed all mid production testing and is fully functional.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2935428-2016-00003 |
| MDR Report Key | 5401487 |
| Report Source | FOREIGN |
| Date Received | 2016-01-27 |
| Date of Report | 2015-12-04 |
| Date Mfgr Received | 2015-12-04 |
| Date Added to Maude | 2016-02-01 |
| 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 Street | 557 MC CORMICK STREET |
| Manufacturer City | SAN LEANDRO CA 94577 |
| Manufacturer Country | US |
| Manufacturer Postal | 94577 |
| Manufacturer Phone | 5103573952 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MID LABS |
| Generic Name | VITREOUS CUTTER |
| Product Code | MLZ |
| Date Received | 2016-01-27 |
| Model Number | 2405CE |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. |
| Manufacturer Address | SAN LEANDRO CA 94577 US 94577 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-27 |