MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-05-14 for MI-1000 061515-V manufactured by Medical Illumination International Inc..
[145769101]
The product from customer complaint # (b)(4) was received and an investigation was initiated. A visual inspection showed that the arm support fitting (p/n 1002036) failed with no other apparent damage. We performed a structural analysis iaw failure analysis of the mi-1000 dated 07/16/2015. We reviewed the porosity of the material and found nothing irregular. The product was rebuilt so we could perform capacity testing. The unit passed a 6x load test for 24+ hours. We were unable to determine the reason for the failure. The potential for misuse is always present but we were unable to definitively tie this failure to any abuse or misuse. This brakeage is unusual as this was the only reported brakeage of this type of the (b)(4) arms shipped in 2015. Note: this report is late because it was sent to the test emdr instead of production.
Patient Sequence No: 1, Text Type: N, H10
[145769102]
On (b)(6) 2017 an incident was reported to medical illumination regarding an mi-1000 arm support fitting fractured causing the light to fall. No injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028295-2018-00001 |
| MDR Report Key | 8609538 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-05-14 |
| Date of Report | 2018-01-23 |
| Date of Event | 2017-10-25 |
| Date Mfgr Received | 2017-10-25 |
| Device Manufacturer Date | 2015-05-30 |
| Date Added to Maude | 2019-05-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT HESS |
| Manufacturer Street | 547 LIBRARY STREET |
| Manufacturer City | SAN FERNANDO CA 91340 |
| Manufacturer Country | US |
| Manufacturer Postal | 91340 |
| Manufacturer Phone | 8188383025 |
| Manufacturer G1 | MEDICAL ILLUMINATION INTRNATION INC. |
| Manufacturer Street | 547 LIBRARY STREET |
| Manufacturer City | SAN FERNANDO CA 91340 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91340 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MI-1000 |
| Generic Name | MINOR SURGICAL LIGHT |
| Product Code | FST |
| Date Received | 2019-05-14 |
| Returned To Mfg | 2017-11-07 |
| Model Number | 061515-V |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ILLUMINATION INTERNATIONAL INC. |
| Manufacturer Address | 547 LIBRARY STREET SAN FERNANDO CA 91340 US 91340 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-14 |