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

Model Number	CH00000001
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the light head fell out of spring arm and cracked in or 3.It was further reported the light head hit a user resulting in a small cut but did not require medical intervention.
Additional Manufacturer Narrative
It was reported that a chromophare spring arm disconnected from the suspension and hit a nurse.The nurse received a small cut but did not require medical intervention.Per the risk file, rsk 12227 revision t, this case has a severity of s1.The light head is connected to the spring arm with a safety segment that is secondly secured with a rotated cover.The cover is held in place by an m3 screw.In or3, this screw was identified as missing; this is the root cause for the separation.With a missing m3 screw, the cover can rotate so the safety segment is exposed.With use, it is possible for the segment to get out of position and no longer secure the light head.If any further information is received, a supplemental will be filed.
Additional Manufacturer Narrative
[supplemental 001] catalog number and gtin were updated.
Event or Problem Description
It was reported the light head fell out of spring arm and cracked in or 3.It was further reported the light head hit a user resulting in a small cut but did not require medical intervention.

• 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: 15432655
• Report Number: 0008010153-2022-00010
• Device Sequence Number: 12180913
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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): 12/06/2022

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
• Device Model Number: CH00000001
• 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: 08/19/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 12/06/2022
• 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