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

Model Number	CH00000001
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a nurse that a blue dome cover has fully separated.There were no reported injuries or adverse consequences.
Additional Manufacturer Narrative
It was reported that the blue dome cover separated from the f generation light.There was no patient involvement, no injuries, no adverse consequences or delay.Per rsk12227 revision v, the severity is s0.The exact root cause for the dome separation is unknown and return of the product to stryker is pending.Once further information is obtained, a supplemental will be filed.
Event or Problem Description
It was reported by a nurse that a blue dome cover has fully separated.There were no reported injuries or adverse consequences.
Additional Manufacturer Narrative
Nurse emailed in blue dome cover has fully separated salesforce case number (b)(4).As reported this issue was observed during morning cleaning setup.Picture provided confirms the issue of separation.Dhr of the affected product was reviewed and it evident that it passed inspection at the time of manufacturing.This is an old light head which was manufactured in year 2014.Manual 700000335 has proper instructions to replace the covers.Potential cause of this issue could be normal wear and tear due to age of the product.There was no patient involvement or adverse consequence reported.If further information is obtained a supplemental will be filed.H3 other text : 81.

• 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: volker hornscheidt ; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532 ; 74611810
• MDR Report Key: 16911687
• Report Number: 0008010153-2023-00012
• Device Sequence Number: 7205619
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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 Model Number: CH00000001
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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