MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR

Model Number A22201A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

The technical assistance group informed the sales representative/user facility that the third party generator (megadyne) was not listed in the instructions for use manual and was not able to provide the recommended settings for use with the referenced device.The device was not returned for evaluation, therefore, the cause of the reported event could not be conclusively determined.A review of the device history records could not be performed as no lot number was provided.Additionally, multiple follow ups were made in an attempt to gather additional information on the reported event; but no additional information was obtained.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The technical assistance group was informed that the loop wire at the distal tip of the hf-resection electrode failed during procedure.The sales representative reportedly observed the procedure when the loop wire broke after thirty minutes of use.The user replaced the broken hf-resection electrode with a second-like device and was able to complete the procedure.There was no patient injury reported.The hf-resection electrode will not be returned for evaluation.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR
• Type of Device: HF-RESECTION ELECTRODE, LOOP
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 9816407
• MDR Text Key: 198150690
• Report Number: 9610773-2020-00089
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761021302
• UDI-Public: 04042761021302
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22201A
• Device Catalogue Number: A22201A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1