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

Catalog Number UNK_SCC

Device Problem Unintended Movement (3026)

Patient Problem Concussion (2192)

Event Date 10/19/2023

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The part number is not known at this time, therefore the gtin and 510 is not known.However, should it become available it will be provided in future reports.

Event Description

It was reported that that drifting issues resulted in a concussion to a staff member.The staff member reportedly missed 2 weeks of work due to this issue.

Manufacturer Narrative

Multiple attempts were made to gather additionally details around the failure.No field service report was provided, root cause is unknown and unable to verify if the issue is resolved.The severity level of the reported incident cannot be determined.Probable root cause for the reported failure could not be determined based on insufficient information.This complaint investigation was closed based because no detailed information for the reported event was obtained after multiple attempts, therefore the reported failure mode was not confirmed.In the event that additional details of equipment involved, serial numbers, medical reports, and technical service report are provided, the complaint will be reopened and the investigation will be updated with new results.

Event Description

It was reported that drifting issues resulted in a concussion to a staff member.The staff member reportedly missed 2 weeks of work due to this issue.

• Brand Name: UNKNOWN_COMMUNICATION_PRODUCT
• 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: josh phillips ; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532 ; 74611810
• MDR Report Key: 18171466
• MDR Text Key: 328548794
• Report Number: 0008010153-2023-00021
• Device Sequence Number: 1
• Product Code: FSY
• 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: 03/22/2024

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: Health Professional
• Device Catalogue Number: UNK_SCC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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