MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH RESECTOSCOPE SHEATH, 22FR; RIGID ENDOSCOPE SHEATH, REUSABLE

Model Number	26055CB
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As per manufacturer incident report #(b)(4) received from the factory in (b)(4): the event occurred in (b)(6).According to the information available, the ceramic tip of the 26055cb broke in the patient's uterus.A few of the broken parts are still in the patient's uterus.
Additional Manufacturer Narrative
The affected device was requested for further investigation, but has not returned yet.
Additional Manufacturer Narrative
The instrument has dents on the shaft.These occur when the inner shaft is not pulled straight out of the outer shaft.Pulling out the inner shaft at an angle exerts pressure on the ceramic insert, causing it to break.It is already included in the ifu that there is a risk of injury if the device is overloaded.

• Brand Name: INNER SHEATH RESECTOSCOPE SHEATH, 22FR
• Common Device Name: RIGID ENDOSCOPE SHEATH, REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 14311358
• Report Number: 9610617-2022-00055
• Device Sequence Number: 5223539
• Product Code: HIH
• UDI-Device Identifier: 04048551275597
• UDI-Public: 4048551275597
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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: 26055CB
• Device Catalogue Number: 26055CB
• Device Lot Number: NR01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female