MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMAROLLER", ROLLER, 24 FR., 12-30, ESG TURIS; PLASMA ROLLER

Model Number	WA22751S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Olympus technical support had noted the customer had resolved the issue.No troubleshooting was needed.The subject device referenced in this report was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported to olympus that the roller ball fell off the roller during a procedure.It was not determined if the ball fell into the patient or on the ground.The patient had x-rays, however, the roller ball was not located in the patient.The facility will monitor the patient.No patient harm was reported.
Additional Manufacturer Narrative
This supplemental report is submitted to provide the results of the the legal manufacturer¿s investigation.The legal manufacturer performed an investigation.The dhr review could not be performed as no lot number was reported and there was no device return to inspect for a lot number.However, the manufacturing and quality control review was performed for the last 24 months of production and there were no non-conformities or deviations regarding the described issue.The cause of the reported issue was most likely due to wear and tear.The loop at the distal end of the electrode wears out during use and may break, burn, or melt.Corrected data: the aware date for initial medwatch report # 9610773 - 2021 - 00117 is march 29, 2021.

• Brand Name: HF-RESECTION ELECTRODE "PLASMAROLLER", ROLLER, 24 FR., 12-30, ESG TURIS
• Common Device Name: PLASMA ROLLER
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 11665110
• Report Number: 9610773-2021-00117
• Device Sequence Number: 3072882
• Product Code: FAS
• UDI-Device Identifier: 14042761085486
• UDI-Public: 14042761085486
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: WA22751S
• Device Catalogue Number: WA22751S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1