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

Catalog Number CH00000001

Device Problem Unintended Movement (3026)

Patient Problem Head Injury (1879)

Event Date 01/05/2024

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the light drifted down and the surgeon was hit in head walking into it.The surgeon required stitches.

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 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
• Type of Device: 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: volker hornscheidt ; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532 ; 74611810
• MDR Report Key: 18625082
• MDR Text Key: 334341697
• Report Number: 0008010153-2024-00002
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2024

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
• Device Operator: Other
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other