inforMED
MalfunctionFEM

WM-NP2 WORKSTATION SET 4 (US)

Received Oct 2, 2023 · Event occurred Aug 7, 2023

Report 9611174-2023-00041 · MDR key 17850824

Device

Generic name

Wm-*p2 Series Of Endoscopy Workstations

Model number

K10021611

Product problems

  • Break
  • Break

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE CUSTOMER HAD REQUESTED AN ONSITE VISIT AND REPAIR BY AN OLYMPUS FIELD SERVICE ENGINEER (FSE) FOR A CASTOR WHEEL THE WM-NP2 WORKSTATION. DURING THE ONSITE VISIT, THE FSE FOUND THE CASTER WHEEL HAD BEEN SNAPPED OFF AND THE BOLT SECURING THE WHEEL SHEARED OFF AND WAS STUCK IN THE BASE OF THE CART. THE BOLT WAS ALSO NOT ABLE TO BE BACKED OUT THE BASE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING DEVICE EVALUATION.

Additional Manufacturer Narrative

THE OLYMPUS FIELD SERVICE ENGINEER (FSE) ARRIVED ON SITE AND FOUND UNIT OUTSIDE OF BIOMED LOCATION. THE CASTOR WHEEL WAS ALREADY OFF OF THE CART. THE FSE INFORMED CUSTOMER THAT THE CART COULD NOT BE REPAIRED AND RECOMMENDED A REPLACING THE CART. THE INVESTIGATION IS ONGOING AND FOLLOW-UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND FEEDBACK FOM THE FIELD. THE FIELD SERVICE ENGINEER (FSE) WAS ONSITE (B)(6) 2023 AND CONFIRMED THAT THE UNIT IS UNREPAIRABLE. THE CUSTOMER HAD SNAPPED OFF THE CASTER WHEEL AND THE BOLT SECURING THE WHEEL SHEARED OFF AND WAS STUCK IN THE BASE OF THE CART. THEY WILL NOT BE ABLE TO BACK OUT THE BOLT EITHER AND HAVE REQUESTED A QUOTE FOR A NEW CART AND DISCARDING THE CART. ADDITIONAL INFORMATION CLARIFIED THE LEFT REAR WHEEL BROKE OFF WHY THE CART WAS BEING MOVED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. HOWEVER, THE CAUSE OF THE EVENT IS LIKELY DUE TO METAL FATIGUE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.