MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE; WA00013A

Model Number	WA00013A
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the customer described "electrosurgical resection device", olympus selected ¿wa22302d¿ as a representative product.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported during an unknown procedure, tissue was not properly coagulated.This resulted in the patient bleeding heavily with approximately 1000 ml intraoperative blood loss.The customer immediately replaced the electrosurgical resection device, promptly located the bleeding site, and performed hemostasis and coagulation.Additional information regarding the patient's condition during the procedure, current condition, and procedural details were requested, but no further information was provided at the time of this report.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received from the customer and correction to the initial mdr.Updated fields: b5, d9, d10, h2, h6, h11.Corrected fields: d1, d2, d3, d4, g1, g4, h5.The correct registration number is 9610773.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
Additional information was received.The customer reported that the saline solution cable was damaged.No further event details were provided at the time of this report.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: h2, h6, h11 attempts were performed to obtain further additional information, but no response was received from the customer.Based on the results of the investigation, and since the device was not returned for evaluation, the reported failure was not confirmed and the definitive root cause of the reported issue could not be determined.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• Brand Name: HF-CABLE
• Common Device Name: WA00013A
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 801 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 23660857
• Report Number: 3007960282-2025-00219
• Device Sequence Number: 9082417
• Product Code: FAS
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K100275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2026

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: WA00013A
• 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): Follow-Up
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 05/16/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/28/2026; 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UES-40 ELECTROSURGICAL UNIT (B)(6).; UES-40 ELECTROSURGICAL UNIT (SN (b)(6)); WA22302D HF-RESECTION ELECTRODE; WA22302D HF-RESECTION ELECTRODE.; WA2T412A TELESCOPE; WA2T412A TELESCOPE.
• Patient Age: 56 YR
• Patient Sex: Male