MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RESECTOSCOPE SHEATH INNER TUBE

Model Number 26040XA

Device Problems Material Separation (1562); Dent in Material (2526)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

Our evaluation found that the shaft is dented and creased, the beak is broken off and the broken piece was not returned.It appears the sheath was serviced by a third party and they tried to erase the karl storz name, part number and date code from the shaft (all information is still visible but is not clear).

Event Description

Allegedly, during a holad urology procedure, the ceramic beak of the inner resectoscope sheath broke off inside the patient's bladder and was retrieved.

• Brand Name: RESECTOSCOPE SHEATH INNER TUBE
• Type of Device: RESECTOSCOPE SHEATH INNER TUBE
• 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: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 7303290
• MDR Text Key: 101476186
• Report Number: 9610617-2018-00017
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551092057
• UDI-Public: 4048551092057
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 26040XA
• Device Catalogue Number: 26040XA
• Device Lot Number: XW01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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