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 Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that a light head disengaged from the cardanic at (b)(6) and a nurse received minor wrist strain catching the light head.She guided the light head to the ground after separation.The nurse did not receive any medical attention as a result of the event.There were no adverse consequences to patients or delays in surgery.The light was returned to stryker communications.Upon review it was found that cover ring was not seated and this in turn caused the snap ring, that secures these two components, to be out of place and prevented the brake screw from fully seating.It is unknown how this happened; potential root causes include service by non-stryker personnel or manufacturing issues.If any further information is obtained around the malfunction; a supplemental will be filed.

Event Description

It was reported and f628 light fell during a case and a nurse received a minor wrist strain catching the light head.There was no reported medical treatment received by the nurse or any adverse consequences to the patient involved in the surgery.

Manufacturer Narrative

There has been a corrected data update made to the following fields: health impact code grid and component code grid.

Event Description

It was reported and f628 light fell during a case and a nurse received a minor wrist strain catching the light head.There was no reported medical treatment received by the nurse or any adverse consequences to the patient involved in the surgery.

• 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: 10514654
• MDR Text Key: 217446171
• Report Number: 0008010153-2020-00007
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1