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

Model Number 26055CB

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/13/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The affected device was requested for further investigation, but has not returned yet.

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
• Type of Device: 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
• MDR Text Key: 292595983
• Report Number: 9610617-2022-00055
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551275597
• UDI-Public: 4048551275597
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 04/14/2022
• Supplement Dates FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female