MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VERSAPOINT BIPOLAR ELECTRODE RESECTOSCOPIC - 2.5 MM ANGLED LOOP, RESECTING; HF-RESECTION ELECTRODES

Model Number	WA47786A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Event or Problem Description
Olympus was informed that during an unspecified procedure 2 hf-resection electrodes caused the generator to issue error message e200.The error message still occurred after the hf-cable and the hf-generator had been replaced.The error message only disappeared when a third hf-electrode was used.The intended procedure was completed, however the failure of the two electrodes led to a delay of the procedure of approx.1 hour.There was reportedly no impact on the patient other than the prolonged procedure time.
Additional Manufacturer Narrative
Corrected data: b1 - report type.Device evaluation: the suspect medical device as well as the second hf electrode that was reported to have failed during the procedure were returned to the manufacturer for investigation/evaluation.The investigation did not reveal any defect or malfunction of the two hf resection electrodes.The hf generator immediately recognized the electrodes and did not display any error messages.Based on the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be determined and is being judged as unknown.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot numbers of both hf resection electrodes without showing any abnormalities.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results.

• Brand Name: VERSAPOINT BIPOLAR ELECTRODE RESECTOSCOPIC - 2.5 MM ANGLED LOOP, RESECTING
• Common Device Name: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): GYRUS MEDICAL LTD.; fortran road; st. mellons; cardiff
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 15445131
• Report Number: 9610773-2022-00418
• Device Sequence Number: 11949670
• Product Code: HIH
• UDI-Device Identifier: 14042761086254
• UDI-Public: 14042761086254
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA47786A
• Device Catalogue Number: WA47786A
• Device Lot Number: U2202014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED HF-CABLE.; UNSPECIFIED HF-GENERATOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown