MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. WM-NP1 110-120V EXERA II CART; WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number K10000285

Device Problem Break (1069)

Patient Problem Shock (2072)

Event Date 10/31/2016

Event Type  Injury  

Manufacturer Narrative

Olympus followed up with the user facility to obtain additional information regarding the reported event and was informed that the cart was operational prior to being struck by another surgical unit.It is unknown if the user required treatment.The broken switch and the cart will not be returned to olympus for evaluation.The customer reported the broken switch was replaced and discarded.The cart was then tested and found to be operational and safe.The most likely cause of the reported event can be attributed to impact damage due the cart coming in contact with the surgical unit.The instruction manual warns users ¿electrical safety checks should only be performed by suitably qualified personnel.The expected service life of the workstation and transformer is 5 years.Maintenance checks should be performed to ensure the workstation remains in a good, safe working condition.Failure to perform these checks could lead to a potentially unsafe workstation.¿.

Event Description

Olympus was informed that during or set up the user received a significant shock after pressing the broken main power switch button on the cart.

• Brand Name: WM-NP1 110-120V EXERA II CART
• Type of Device: WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS
• Manufacturer (Section D): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.; keymed house, stock road; southend-on-sea, essex SS2 5 QH; UK SS2 5QH
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6120318
• MDR Text Key: 60647695
• Report Number: 2951238-2016-00877
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K10000285
• Device Catalogue Number: K10000285
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other