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

Model Number CH00000001

Device Problem Mechanical Problem (1384)

Patient Problem Pain (1994)

Event Date 08/19/2022

Event Type  malfunction  

Event 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.

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.

Manufacturer Narrative

[supplemental 001] catalog number and gtin were updated.

Event 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
• 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: 15432655
• MDR Text Key: 300324067
• Report Number: 0008010153-2022-00010
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/15/2022
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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