MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE LOOP 24 FR; ENDOSCOPE, AC-POWERED AND ACCESSORIES

Model Number	A22205C
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The referenced device will not be returned to olympus, therefore, the exact cause of the reported event cannot be confirmed.The oem conducted a dhr review; manufacturing and quality control review was performed for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.Based on similar reported complaints, the reported event can potentially occur if the electrode comes into unintended contact with other metal parts, e.G., surgical instruments while the high-frequency output was activated.As a preventive measure, the instructions for use contains several warning and caution statements to prevent damage to the electrode: "visually inspect the instrument prior to use.Warped electrodes, defective insulation and broken, cracked, or irregular cutting loops represent a danger for both the patient and the surgeon and must not be used.If the instrument is damaged or does not function properly, replace it." if additional information is received it will be reviewed and a supplemental report will be filed.
Event or Problem Description
The user facility reported that the device that became faulty during a therapeutic endometrial resection procedure.Sales representative reported "very routine procedure until 3/4 through when loop was observed to have burnt and disintegrated." the surgeon checked with a scope and did not find any device fragments inside the patient.The same loop device was not used to completed the procedure.There was no patient injury reported or need for medical intervention to prevent serious injury.
Additional Manufacturer Narrative
The referenced device was returned for evaluation of the reported ¿loop wire burnt and disintegrated¿.A visual inspection was performed and the distal end loop wire and tip were damaged as the loop wire was split/broken.A piece of the loop wire appears to be disintegrated.The distal end was further inspected and noted that the top section of the yellow colored insulated sheath was burnt with char marks.The shaft of the electrode was inspected and was noted slightly bent.An activation test could not be performed due to the damaged loop wire.Based on the evaluation and similar reported events, the cause to the damaged loop wire was potentially due to operational error.

• Brand Name: HF-RESECTION ELECTRODE LOOP 24 FR
• Common Device Name: ENDOSCOPE, AC-POWERED AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 9124368
• Report Number: 9610773-2019-00128
• Device Sequence Number: 14087735
• Product Code: GCP
• UDI-Device Identifier: 14042761036709
• UDI-Public: 14042761036709
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K931764
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A22205C
• Device Catalogue Number: A22205C
• Device Lot Number: 1000037579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1