MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP; UNIT, ELECTROSURGICAL, ENDOSCOPIC

Model Number A22201C

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/14/2023

Event Type  Injury  

Manufacturer Narrative

This report has been submitted by the importer under this mdr report number 2429304-2023-00272 the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported that during a therapeutic urology procedure using the hf resection electrode, the loop broke off and fell into the patient and was unable to be located.It remained in the patient.The procedure was prolonged "dramatically." it was reported that the condition of the patient and the diagnostic outcome was impacted by the failure, but it was not specified how.The procedure was completed with another device.Reportedly, a diagnostic intervention will be undertaken to locate the missing device piece left in the patient¿s body (mri/x-ray).Additional follow up has been conducted regarding the broken piece left in the patient and the patient outcome; however, the information was not available at the time of report.

• Brand Name: HF-RESECTION ELECTRODE, LOOP
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17702520
• MDR Text Key: 322883406
• Report Number: 9610773-2023-02490
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 14042761036648
• UDI-Public: 14042761036648
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/07/2023

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
• Device Operator: Health Professional
• Device Model Number: A22201C
• Device Lot Number: 1000112793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: FY24-EMEA-01
• Patient Sequence Number: 1
• Patient Outcome(s): Other