MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY HOPKINS RIGID TELESCOPE

Model Number	26120BA
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Scope has not been returned for evaluation.
Event or Problem Description
Allegedly, the doctor was performing a d & c hysteroscopy with ablation on patient, when she removed scope from uterus and noticed a piece of the scope distal window was cracked and missing.They brought in another scope and completed procedure.Doctor went back in to check if piece was inside patient.She didn't find it; no x-ray was performed.Doctor doesn't have plans to schedule another procedure to locate missing piece.She believes that it was flushed out during irrigation.The hospital reported there was no injury to the patient.
Additional Manufacturer Narrative
The distal window seal is broken.Possible causes can be the epoxy coming undone on distal lens window.Excessive or prolonged heat will cause this along with trauma to the instrument distal tip.We cannot confirm cause.
Event or Problem Description
This is a supplemental.I will be adding method/results/conclusion codes and evaluation of the instrument.

• Brand Name: HOPKINS RIGID TELESCOPE
• Common Device Name: RIGID TELESCOPE
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• MDR Report Key: 6613568
• Report Number: 9610617-2017-00041
• Device Sequence Number: 10766770
• Product Code: FAJ
• UDI-Device Identifier: 04048551093832
• UDI-Public: 4048551093832
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K943176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2017

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: 26120BA
• Device Catalogue Number: 26120BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1