MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMANEEDLE"

Model Number	WA22740S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is in progress; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The sales representative was informed that the user facility was using the high frequency resection plasma needle electrode and the tip broke off at the beginning of an unspecified procedure.The broken tip was retrieved from the patient.No patient death, serious injury or infection was reported.
Additional Manufacturer Narrative
As part of the investigation, olympus followed up with the user facility to obtain additional information regarding the reported event (including sections e2 and e3) but with no results.The oem performed the device history records for the concerned device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The concerned device was not returned for evaluation; therefore, the root cause of the reported event cannot be conclusively determined.However, as no error message (e.G.Short-circuit) of the generator used was reported, improper handling or excessive force cannot be ruled out as the potential cause of the damage.The oem will continue to monitor complaints for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMANEEDLE"
• Common Device Name: HF-RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 12203071
• Report Number: 9610773-2021-00201
• Device Sequence Number: 1323629
• Product Code: FAS
• UDI-Device Identifier: 14042761085431
• UDI-Public: 14042761085431
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K171965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA22740S
• Device Catalogue Number: WA22740S
• Device Lot Number: 1000050873
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1