MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE; WORKING ELEMENTS (MONOPOLAR, BIPOLAR, FOR KNIVES, FOR PROBES)

Model Number	WA22367A
Medical Device Problem Codes	Output Problem (3005); Activation Problem (4042)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/15/2021
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 a therapeutic hysteroscopic procedure it was not possible to effectively cut tissue and stop the bleeding.Error e006 was issued on the hf generator due to poor contact between electrode and hysteroscope base.The surgeon then used a forceps to bend and firmly connect the electrode to the base of the hysteroscope.The intended procedure was then completed.However, the failure led to a significant prolongation of the surgery time and significantly increased bleeding.
Additional Manufacturer Narrative
The suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the evaluation/investigation was performed exclusively based on the available information.The exact cause of the patient¿s outcome could not be conclusively determined.However, based on the information provided, we assume that the electrode was not installed properly and/or that its secure fit was not checked correctly before the procedure, which most likely led to the damage of the internal electrical contact.Due to insufficient contact between the electrode and the internal electrode contact, the generator then correctly displayed error message e006.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the working element 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 and the user will be informed about the investigation results.

• Brand Name: WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE
• Common Device Name: WORKING ELEMENTS (MONOPOLAR, BIPOLAR, FOR KNIVES, FOR PROBES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 13222539
• Report Number: 9610773-2022-00048
• Device Sequence Number: 1701154
• Product Code: KNS
• UDI-Device Identifier: 04042761066242
• UDI-Public: 04042761066242
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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: WA22367A
• Device Catalogue Number: WA22367A
• Device Lot Number: 18ZW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS ESG-400 HF-GENERATOR (WB91051C); OLYMPUS HF-CABLE (WA00014A)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female