MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-14 for MI-1000 061515 manufactured by Medical Illumination Intrnation Inc..
[145769413]
The product from customer complaint # (b)(4) was received and an investigation was initiated. The double ceiling mounts p/n 1002060 are two parts clamped together. The first half had no breaks. Th second half had breaks in two places. Visual inspection of the broken parts with the aid of magnification no porosity or voids were present. One of the abashing s/a/s, p/n 1000234, had the first two threads stripped out, minimizing thread engagement and reducing the clamping force by that one screw location, which may have caused some weakness in the total clamping force. When we went to the facility, only 2 screws were present in the mounting assembly. The facility staff did not know if all the screws were installed when the p/n 1002060 part broke, but these screws were not present upon our arrival. It is suspected that the screws used to secure both halves together (screws p/n 0001291, 8 places) were not sufficiently tightened, or missing causing the combined lack of strength required to maintain the structural integrity of the clamping force for the entire mounted assembly. The one stripped out thread location in the p/n 10000234 bushing s/a may have caused some weakness, if the screw was not present or was not engaged. We were not able to determine if the 2 screws were installed correctly on the other side of the assembly. All 8 screws must be installed per the instructions for use manual to insure adequate system strength. The combined stress on the p/n 1002060 casting with only 2 screws installed would be high and could cause part to fail. It is our assumption that the missing screws caused the failure. Note: this report is late because it was sent to the test emrd instead of production. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[145769414]
On (b)(6) 2018 an incident was reported to medical illumination regarding a dual ceiling mount mi-1000 where one half of the ceiling mount casting broke, causing one of the two lights on the mount to fall. The (b)(4) stated there were minor injuries sustained when the charge nurse tried to catch the light, straining her arm, and striking the dr. In the head (slight headache). It was also said that the patient was grazed on the left shoulder causing a small tear in his shirt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028295-2018-00004 |
| MDR Report Key | 8609917 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-14 |
| Date of Report | 2018-02-05 |
| Date of Event | 2018-01-12 |
| Date Mfgr Received | 2018-01-12 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 | 2018-01-23 |
| Model Number | 061515 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ILLUMINATION INTRNATION INC. |
| Manufacturer Address | 547 LIBRARY STREET SAN FERNANDO CA 91340 US 91340 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-14 |