MAUDE Adverse Event Report: ILLUMINOSS MEDICAL, INC PHOTODYNAMIC BONE STABILIZATION SYSTEM; IN VIVO INTRAMEDUILLARY FIXATION ROD

Catalog Number SY-2000-01

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 01/27/2023

Event Type  malfunction  

Event Description

An illuminoss distributor reported that during a routine safety inspection to bring an illuminoss photodynamic light source (a.K.A.Light box) into the hospital, the light box failed its safety test.

Manufacturer Narrative

At the time of this initial mdr report, the investigation into the cause of the event is still ongoing.The distributor reported that the hospital's biomed engineer identified the device problem, at which point the distributor returned the device to the firm.There was no user or patient involvement.The firm has conducted a review of the manufacturing records for the device, and found that the device met specifications at the time of manufacture and release.On (b)(6) 2023, the firm received the returned device from the distributor.The firm is performing device evaluation in order to complete the complaint investigation.A follow up mdr will be submitted when further information is known about this case.

Manufacturer Narrative

At the time of this followup report, the investigation into the cause of the event is still ongoing.This report is submitted to submit new information, including : the device manufacture date.Usage of the device info.An update on the progress of the on-going product evaluation activities the firm is performing.The firm received the returned device from the distributor, and began 4 rounds of product evaluation to replicate the failure mode reported.Round 1: in house product evaluation on the returned device was performed on 27feb2023.These preliminary results were inconclusive.Round 2: in house product evaluation was performed again on the returned device, with 3rd party electronics consulting supplier, with alternative testing equipment.The failure mode could not be replicated.Round 3: the device was sent to the firm's contract manufacturer for this device for additional product evaluation, to attempt to replicate the failure mode.The contract manufacturer provided the firm with its analysis on 22mar2023, which concluded that the reported device failure mode was not able to be replicated.Round 4: based on these results, the firm determined to perform a final round of product evaluation, with 3rd party electronics specialists, in an effort to replicate the failure with this device.A follow up mdr will be submitted when firm completes the in process device evaluation activities.

Manufacturer Narrative

At the time of the previous mdr submissions for this event, the investigation into the cause of this event was still underway.This followup mdr is submitted to submit new information, including.Product evaluation results of returned complaint device.Updated investigation type codes, investigation findings codes, and investigation conclusion codes.And this manufacturer's narrative with the firm's root cause conclusions.The firm received the returned device from the distributor, and began 4 rounds of product evaluation to replicate the failure mode reported.In house product evaluation on the returned device was performed on (b)(6) 2023.These preliminary results were inconclusive.In house product evaluation was performed again on the returned device, with 3rd party electronics consulting supplier, with alternative testing equipment.The failure mode could not be replicated.The device was sent to the firm's contract manufacturer for this device for additional product evaluation, to attempt to replicate the failure mode, and perform a complete diagnostic of the device.The contract manufacturer provided the firm with its analysis on (b)(6) 2023, which concluded that the reported device failure mode was not able to be replicated, and no damage or fault was identified in this device.Based on these results, the firm performed an additional round of product evaluation, with 3rd party electronics specialists, in an effort to replicate the failure with this device.This evaluation was able to replicate the failure mode, and verify that the intermittent, inconsistent failure mode observed was related to the unit's ac filter inlet where the power cord plugs in.It was determined this was a partially damaged or compromised component.Although it could not be definitely proven with the information available to the firm, a possible cause of this damaged/compromised component is excessive force being applied when plugging in or removing the power cord.Conclusion the definitive cause of the failure could not be determined.Product evaluation was able to identify that a damaged or compromised ac filter inlet led to the observed failure.Although a possible cause of this damaged/compromised component is excessive force being applied when plugging in or removing the power cord, this could not be confirmed with the information available to the firm.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN VIVO INTRAMEDUILLARY FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL, INC; 93 waterman ave; east providence RI 02914
• Manufacturer (Section G): ILLUMINOSS MEDICAL, INC; 993 waterman ave; east providence RI 02914
• Manufacturer Contact: robert rabiner ; 993 waterman ave; east providence, RI 02914 ; 4017140008
• MDR Report Key: 16437327
• MDR Text Key: 310268834
• Report Number: 3006845464-2023-00007
• Device Sequence Number: 1
• Product Code: QAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: SY-2000-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2019
• 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