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

Catalog Number	CH00000001
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the flat panel monitor is only hanging onto the arm by a few cables in or 4.It is believed that something internal in the arm is damaged.There were no reported injuries or adverse consequences.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
It was reported that a flat panel monitor was only hanging onto the arm by a few cables.Based on interview with field service technician (fst), it was confirmed that spring arm broke and it was replaced, resolving the issue.Equipment was tested and left working as intended.The fst reported that failure consisted of the internal component of the yoke (threaded rod inside the spring arm) snapped.Also, berchtold legacy spring arm was involved in the failure, the fst estimates this installation was from 2014-2016 (approx.10 years ago).The other components of the flat panel didn¿t get any damage and were left working as expected when the account was serviced.No part number or serial number available or reported, therefore unable to request manufacturing dhr for investigation.Although the exact root cause of this issue is unknown, the most likely root cause would be maintenance and wear of this legacy product.This identified failure mode exceeds threshold and will continue to be monitored.The rate of failure (complaints over shipments) for this threshold in the time frame considered is (b)(4).All complaints were reviewed by our data analyst, and all cases were previously assessed at s1 or s0.This failure mode will continue to be monitored.If any further information is received, a supplemental will be filed.
Event or Problem Description
It was reported that the flat panel monitor is only hanging onto the arm by a few cables in or 4.It is believed that something internal in the arm is damaged.There were no reported injuries or adverse consequences.

• Brand Name: CHROMOPHARE
• 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: 19291756
• Report Number: 0008010153-2024-00009
• Device Sequence Number: 8687472
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K120392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 10/25/2024
• 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
• Patient Sex: Unknown