MAUDE Adverse Event Report: MEDICAL ILLUMINATION INTRNATION INC. MI-750; MINOR SURGICAL LIGHT

Model Number 061424

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2022

Event Type  malfunction  

Event Description

On december 16th, it was reported to medical illumination that an mi750 light system has separated from the down tube.No injuries occured.

Manufacturer Narrative

The field failure (ccr #2754) of an mi-line, single arm, mi-750 light head system (model: 061424) was received (01/12/23) into engineering for failure analysis.The customer states that the unit fell from the ceiling mount.Based on the customer supplied information, the extension arm (1000724-s) with spring arm (1000727-mi750) is hanging from the power cable (1000789).Observations: from the customer supplied information.The supporting snap ring (0003445) and its support washer (0003443) which would have been sitting in the snap ring groove on the end of the shaft (1001462) was not present as expected.If the snap ring had dislodged itself from the groove, it should have been found in the 1001378 hub cover along with the support washer on the far side of the bearing plate (1001464).The condition as received (out of the box) we found the snap ring & the support washer had been installed back onto the snap ring groove on the end of the shaft.The hub cover was in place and mounted on the end of the extension arm housing.It is not possible for the snap ring and support washer to get past the internal bearing plate which is held in place in a counter bore in the extension arm housing.Restoring the assembly to its normal condition: engineering re-built the assembly with the snap ring & support washer.We assured that the snap ring was set properly in its groove and applied force to see if the extension arm held itself in place.We examined the snap ring & the snap ring groove for proper fit and damage.No damage found.Conclusion: there wasn't enough or sufficient detailed information received from the customer to indicate how this failure could have occurred or establish a root cause.If there had been an assembly error, the as received evidence did not indicate it.The as-received, out-of-the-box evidence provided may have been altered making the failure analysis difficult.There isn't any prior incident of this particular failure mode.If additional information can be uptained from the end user, will update report.

• Brand Name: MI-750
• Type of Device: MINOR SURGICAL LIGHT
• Manufacturer (Section D): MEDICAL ILLUMINATION INTRNATION INC.; 19749 dearborn street; chatsworth CA 91311
• Manufacturer (Section G): MEDICAL ILLUMINATION INTRNATION INC.; 19749 dearborn street; chatsworth CA 91311
• Manufacturer Contact: robert hess ; 19749 dearborn street; chatsworth, CA 91311 ; 8188383025
• MDR Report Key: 16184645
• MDR Text Key: 308925838
• Report Number: 2028295-2023-00001
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00816835020201
• UDI-Public: 00816835020201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 061424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1