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 2520CE manufactured by Medical Instrument Development Laboratories, Inc..
[37243855]
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
[37243856]
User facility reported that physician stated 23g, r1, vc (model 2520ce, lot # 13061204) did not work while patient was undergoing surgery. Facility did not know date of event. Procedure was completed, and 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
[53727843]
Upon receipt of product at midlabs (23 gauge, r1 vitreous cutter - model 2520ce, lot 13061204) with the complaint "cutter did not work", examination showed soft bend on needle, tip wobbled when rolled; no other abnormity. 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 midlabs production testing, and is fully functional.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2935428-2016-00002 |
| MDR Report Key | 5401488 |
| Report Source | FOREIGN |
| Date Received | 2016-01-27 |
| Date of Report | 2015-12-04 |
| Date Mfgr Received | 2015-12-04 |
| Device Manufacturer Date | 2013-08-14 |
| 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 AVENUE |
| 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 | 2520CE |
| Lot Number | 13061204 |
| Device Expiration Date | 2016-08-14 |
| 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 |