MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG CHROMOPHARE OR LIGHT CEILING-MOUNTED; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number	CH00000001
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	01/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the light drifted down and the surgeon was hit in head walking into it.The surgeon required stitches.
Additional Manufacturer Narrative
It was initially reported that "the light drifted down and the surgeon was hit in head walking into it" this resulted in stitches being required.However, during the investigation it was later reported and concluded by the sales representative that incident was "was more user frustration/error, than it was a mechanical issue", and that "maintenance did tighten it afterward, they have had no issues since and no one was chronically injured".Multiple attempts were made to gather additional details around the failure.No field service report was provided, root cause is unknown.Furthermore, a recent additional statement from the or manager confirmed that issue was user error: "i was told that prior to his collision with the light that he had swung the light out of the way.Then it circled back around to near the similar position to where it had started.He then collided with it when he didn¿t see its final resting place".Although the exact root cause of this issue is unknown, based on the information reported the issue would be attributed to user error by being unaware of their surroundings (but it is also documented as a potential improper maintenance issue based on the initial complaint reporting).Chromophare surgical lights, single and combination lights service and parts manual was reviewed.Section 7.9 of the manual includes instructions for maintaining and adjusting brake screws in horizontal arms, lights and cardanic.This complaint investigation was closed based on the customer confirming no further issues after they tighten brake screws and performed proper maintenance on the device.If any further information is received, a supplemental will be filed.
Event or Problem Description
It was reported that the light drifted down and the surgeon was hit in head walking into it.The surgeon required stitches.

• Brand Name: CHROMOPHARE OR LIGHT CEILING-MOUNTED
• Common Device Name: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: josh phillips ; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532 ; 74611810
• MDR Report Key: 18625082
• Report Number: 0008010153-2024-00002
• Device Sequence Number: 18153156
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown