MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH SUCTION/IRRIGATION TUBE, 5 X 360 MM, BUTTON, UNIPOLAR, FOR HIQ+ HANDLE; SUCTIONIRRIGATION SYSTEM (HANDLE, VALVE TUBING, SUCTIONIRRIGATION TUBE)

Model Number	WA51138A
Medical Device Problem Codes	Sparking (2595); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/02/2022
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 after completion of a therapeutic laparoscopic spleen cyst removal procedure it was noticed that the patient had sustained a 4th degree skin burn approx.1 cm from the trocar where the monopolar suction/irrigation tube had been inserted.The tissue around the trocar had to be surgically removed due to the burn injury but no further treatment was required.The intended procedure had been performed using a kls martin maxium® electrosurgical generator with the settings cut 33 and coag spray 58.The suction/irrigation tube had been inspected before use and no defects were found but after the surgery its insulation was found to be damaged.
Additional Manufacturer Narrative
Additional information: h6 - medical device problem code.Device evaluation: the suspect medical device was returned to the manufacturer for investigation/evaluation.The investigation confirmed that the insulation (halar coating) of the suction/irrigation tube is burnt.Based on the information provided the use of the spray coagulation feature during the procedure caused a sparkover, which has burnt a hole in the coating.The ¿spray coagulation¿ feature must not be used with this product.This is clearly stated as a warning note in the instructions for use (¿some electrosurgical generators have a so-called ¿spray coagulation¿ feature.Using the ¿spray coagulation¿ feature in combination with the equipment mentioned in this document can cause sparkover leading to electrical injury, thermal injury and unintended nerve stimulation.Do not use the ¿spray coagulation¿ feature.¿) thus, this incident was attributed to user error.Additionally, the investigation found several scratches/cuttings near the hole in the halar coating.It remained unclear if this finding was directly related to the reported incident.However, it is assumed that this damage occurred during disassembly.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the suction/irrigation tube 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: SUCTION/IRRIGATION TUBE, 5 X 360 MM, BUTTON, UNIPOLAR, FOR HIQ+ HANDLE
• Common Device Name: SUCTIONIRRIGATION SYSTEM (HANDLE, VALVE TUBING, SUCTIONIRRIGATION TUBE)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 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: 15769436
• Report Number: 9610773-2022-00525
• Device Sequence Number: 17797393
• Product Code: GCJ
• UDI-Device Identifier: 04042761024341
• UDI-Public: 04042761024341
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• PMA/510(K) Number: K923982
• 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): 11/23/2022

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: WA51138A
• Device Catalogue Number: WA51138A
• Device Lot Number: 20304-0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/02/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown