MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY CUTTING LOOP

Model Number	27050G-S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Allegedly, the doctor was performing a turp when the loop broke off into the patient.The doctor immediately retrieved, replaced instrument and completed procedure.The hospital reported there was no injury to the patient.

• Brand Name: CUTTING LOOP
• Common Device Name: CUTTING LOOP
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• MDR Report Key: 6831508
• Report Number: 9610617-2017-00073
• Device Sequence Number: 1522445
• Product Code: HIH
• UDI-Device Identifier: 04048551394540
• UDI-Public: 4048551394540
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/17/2017

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: 27050G-S
• Device Catalogue Number: 27050G-S
• Device Lot Number: 55199
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2017
• 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: 85 YR