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

Model Number CH00000001

Device Problem Material Erosion (1214)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

It was reported in or 15 prior to procedure a light head became disengaged from a spring arm and struck a doctor, who needed medical intervention for alleged cracked ribs.There was no reported patient involvement in this event.The root cause of the issue in or15 was determined to be separation of mounting hardware due to a cracked cover casing the hardware.The cover helps retain mounting hardware that ensures the light is constrained to the spring arm.After a field investigation, it appears the cover was damaged, which resulted in a changed spacing around the mounting hardware.This allowed the hardware to get out of position.It is unclear how long the light existed in this state before failure, as no service events were reported to stryker concerning these cracked components.After initial inspection and based on current information, the suspected root cause of the cracking is cleaning method.If any further information is found; a supplemental will be filed.

Event Description

It was reported in or 15 prior to procedure a light head fell off of a spring arm and struck a doctor, who needed medical intervention for cracked ribs.There was no reported patient involvement in this event.

Manufacturer Narrative

There has been corrected data updates made to the following fields: outcomes attributed to ae, clinical signs code grid, health impact code grid, and component code grid.

Event Description

It was reported in or 15 prior to procedure a light head fell off of a spring arm and struck a doctor, who needed medical intervention for cracked ribs.There was no reported patient involvement in this event.

• 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
• MDR Report Key: 10261690
• MDR Text Key: 205578192
• Report Number: 0008010153-2020-00006
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

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: No Information
• Device Model Number: CH00000001
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 06/18/2020
• Supplement Dates FDA Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization