MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH SCISSORS "HIQ+", 5 X 330 MM, MINI-METZENBAUM, ERGO

Model Number	A63840A
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Olympus followed up with the user facility via telephone and in writing to obtain additional regarding the patient, procedure and the concomitant devices that were used but no additional information was provided.The referenced device was not returned to olympus.The cause of the reported event could not be confirmed.However, if additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.
Event or Problem Description
Olympus was informed that during an unspecified procedure the tip of the device melted off and fell inside the patient.The tip then fused with the patient.The staff brought in a surgeon to surgically remove the melted piece from the patient.It was also reported that the doctor had the electrosurgical generator turned to 100 watts for an hour.The patient outcome is unknown and it is unknown whether the melted piece was retrieved from the patient or not.
Additional Manufacturer Narrative
This supplemental report is being submitted to correct section h1.

• Brand Name: SCISSORS "HIQ+", 5 X 330 MM, MINI-METZENBAUM, ERGO
• Common Device Name: SCISSORS "HIQ+"
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 8417754
• Report Number: 2951238-2019-00532
• Device Sequence Number: 2249552
• Product Code: HET
• UDI-Device Identifier: 04042761027298
• UDI-Public: 04042761027298
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K944201
• 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): 02/04/2020

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: A63840A
• Device Catalogue Number: A63840A
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention