CHROMOPHARE OR LIGHT CEILING-MOUNTED
Received Sep 10, 2020 · Event occurred Aug 14, 2020
Report 0008010153-2020-00007 · MDR key 10514654
Device
Generic name
Light, Surgical, Ceiling Mounted
Manufacturer
Berchtold Gmbh & Co. KgModel number
CH00000001Catalog number
CH00000001
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Clinical Signs, Symptoms or Conditions
- No Known Impact Or Consequence To Patient
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional 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.
Description of Event or Problem
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.
Additional Manufacturer Narrative
THERE HAS BEEN A CORRECTED DATA UPDATE MADE TO THE FOLLOWING FIELDS: HEALTH IMPACT CODE GRID AND COMPONENT CODE GRID.
Description of Event or Problem
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.