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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 11/02/2021

Event Type  Injury  

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 Description

Olympus was informed that during a therapeutic transurethral resection of a bladder tumor (turbt) procedure, the patient was jerking due to electric nerve stimulation.Consequently, spinal anesthesia was used to complete the surgery.No further information was provided, but there was no report of any product malfunction.

Manufacturer Narrative

Additional information: d10 - concomitant medical products and therapy dates device evaluation: the suspect medical device was not returned to olympus for evaluation/investigation but to olympus medical systems india (omsi), (returned to omsi on 2021-11-08).The evaluation/investigation did not reveal any malfunction of the working element but found the device to be working correctly.The reported working element is thus rated as meeting its specification.The exact cause of the patient¿s outcome and the reported phenomenon could not be conclusively determined and is being judged as unknown.However, based on the information provided, the reported issue can most likely be attributed to use error.When using a bipolar resectoscope (plasma technology), the current exclusively flows between the two poles of the electrode.Therefore, it is assumed that the nerve stimulation that was triggered in this patient is associated with anatomical conditions and the anesthesia that was chosen.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 result.

• Brand Name: WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE
• Type of Device: 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 ; 4940669662
• MDR Report Key: 12909252
• MDR Text Key: 281574397
• Report Number: 9610773-2021-00344
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04042761066242
• UDI-Public: 04042761066242
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K030194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA22367A
• Device Catalogue Number: WA22367A
• Device Lot Number: 195W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• 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
• Treatment: OLYMPUS ELECTROSURGICAL GENERATOR "ESG-400".
• Patient Outcome(s): Required Intervention
• Patient Sex: Female