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 2720CE manufactured by Medical Instrument Development Laboratories, Inc..
[37244121]
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
[37244122]
User facility reported that physician stated that during vitrectomy for intraocular foreign body the cutter stopped functioning after coming into contact with metallic foreign body. The device description is 23g, r3+, vc (model 2720ce, lot # 13100901). Procedure was completed, and no patient injury reported. No delay in treatment, no medical intervention required. The incident was reported to midlabs on (b)(4) 2015. To date, the device has not been returned to midlabs for investigation.
Patient Sequence No: 1, Text Type: D, B5
[54798603]
Upon receipt of product at midlabs (23 gauge, r3 vitreous cutter - model 2720ce, lot 13100901) with the complaint "vitreous cutter stopped functioning after coming into contact with metallic foreign body", examination showed soft bend on needle, tip wobbled when rolled, hairline cracks observed on epoxy bead, over bite trace and a small dent observable on needle cutting edge, cutter edge dull and even. The following tests were conducted: aspiration test: result - no flow; clog removed with wire flush. Tissue cut test: result - 60 cpm tear to no cuts; slow to cut until after clog removed; pass 600 cpm, pass 8000 cpm with asp. Retraction test: result - pass. Leak test: result - pass 50 psi open port and closed port leak tests. Probe aspiration path was clogged by metal particle which was in the patient's eye prior to procedure. Damage observed on both needle port and cutter cutting edges, as well probe needle received with permanent bend, all of which may cause the probe to cut inefficiently or stop cutting altogether. No patient injury reported by user facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2935428-2016-00004 |
| MDR Report Key | 5401483 |
| Report Source | FOREIGN |
| Date Received | 2016-01-27 |
| Date of Report | 2015-12-04 |
| Date of Event | 2015-06-01 |
| Date Mfgr Received | 2015-12-04 |
| Device Manufacturer Date | 2013-11-15 |
| 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 | 2720CE |
| Lot Number | 13100901 |
| Device Expiration Date | 2015-05-15 |
| 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 |