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

Model Number	WA22366A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/19/2020
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 patients 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 after completing a therapeutic transurethral resection of a bladder tumor (tur-bt) procedure, it was noticed that the patient had sustained a second to third degree burn injury on the hand.No further information was provided but the intended procedure was successfully completed using the same set of equipment.
Additional Manufacturer Narrative
Additional information: d4 - lot-number; d10 - concomitant medical products and therapy dates; h4 - device manufacturer date.Correction: d1 - brand name; d2 common device name, device product code; d4 - material number, catalog number; g4 - pma/510(k) number.Device evaluation: the suspect medical device was not returned to the manufacturer for investigation but to olympus medical systems corporation (omsc), japan (returned to omsc on (b)(6) 2020).The investigation confirmed severe corrosion in the electrode¿s locking element and on the instrument¿s surface.This was most likely caused by incorrect reprocessing.Furthermore, the internal electrode fixing port was found to be blocked by a torn-off electrode contact.This type of damage is typical for excessive force.Therefore, this event/incident was attributed to use error.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.However, the reported phenomenon will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: WORKING ELEMENT, ACTIVE, 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
• MDR Report Key: 10470683
• Report Number: 9610773-2020-00198
• Device Sequence Number: 4492145
• Product Code: KNS
• UDI-Device Identifier: 04042761020268
• UDI-Public: 04042761020268
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: WA22366A
• Device Catalogue Number: WA22366A
• Device Lot Number: 06ZW
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS OBTURATOR A22081A / LOT.191W.; OLYMPUS RESECTION SHEATH - A22041A / LOT.15YW.; UNSPECIFIED ERBE VIO ELECTROSURGICAL UNIT.
• Outcome Attributed to Adverse Event: Required Intervention