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

Model Number CH00000001

Device Problems Component Missing (2306); Component Misassembled (4004)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the cardanic cables, brake screws were broken, and needed to be replaced.A stryker field service technician (sfst) was dispatched onsite for investigation.Upon visual inspection the sfst noticed the drop tube and horizontal arm were noticeably separated.The sfst began inspection of the horizontal arm and drop tube.The sfst found the c-clip (retaining light, spring arm, and horizontal arm) to ceiling, completely missing.The sfst released the brake screw, and found the brake screw itself, cracked in half with components falling from horizontal arm.The sfst turned the horizontal arm 1/4 turn and light released from ceiling by itself due to missing safety c-clip.The sfst inspected the arm and found the commutator was set in place by folded paper towels and was missing set screws.The sfst removed light from service and set parts in the electrical room.It was recommended to the customer to replace the horizontal arm and spring arm due to safety concern.Stryker provided a quote for the replacement.There was no injury, or adverse consequence reported.

Event Description

It was reported that the cardanic cables, brake screws were broken, and needed to be replaced.There was no injury, or adverse consequence reported.

Event Description

It was reported that the cardanic cables and brake screws were broken and needed to be replaced.There was no injury or adverse consequence reported.

Manufacturer Narrative

After review, it was determined that the failure mode of the missing c-clip, resulting in the brake screw to crack, has not previously resulted in an adverse consequence to a patient or staff for chromophare e series suspensions.As a result, it has been concluded that an mdr was not required.The initial mdr shall be nullified.

• 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 ; DE 78532
• MDR Report Key: 9521346
• MDR Text Key: 216681547
• Report Number: 0008010153-2019-00020
• 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: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CH00000001
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1