MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY MYOMA FIXATION INSTRUMENT

Model Number	26175BL
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The corkscrew portion of the device is broken off at the base.It has been in use for approximately 5 years.Stress overload is possible cause, but we cannot confirm.
Event or Problem Description
Allegedly, the doctor was performing a myomectomy procedure when the tip of the myoma fixation instrument broke off in a fibroid.The doctor removed the fibroid that encased the broken piece and completed procedure.The hospital reported there was no injury to the patient.

• Brand Name: MYOMA FIXATION INSTRUMENT
• Common Device Name: MYOMA FIXATION INSTRUMENT
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• MDR Report Key: 6831495
• Report Number: 9610617-2017-00071
• Device Sequence Number: 10780226
• Product Code: HET
• UDI-Device Identifier: 04048551099063
• UDI-Public: 4048551099063
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K945211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/08/2017

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: Physician
• Device Model Number: 26175BL
• Device Catalogue Number: 26175BL
• Device Lot Number: ZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 121