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

Model Number 27050CA

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

Per the factory, upon examination we found that the ceramic tip is broken off.The ceramic insert has not been provided.There was sufficient glue between tip and sheath, because the bonded ceramic still adheres well in the inner part of the sheath.The sheath shows proximal corrosion, which can be attributed to incorrect cleaning.Damages like this happen if the ceramic tip is hit against hard objects or edges.The damage of the product is not caused by a production problem or material defect.Hints on how to inspect the ceramic tip are already included in the ifu.

Event Description

Per the factory in (b)(4), allegedly, there was an event occurred in (b)(6) that the tip was broken off during an operation.A second operation was needed to remove the broken part.

• Brand Name: INNER SHEATH
• Type of Device: UROLOGY RESECTOSCOPE INNER SHEATH
• 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 ; 4242188201
• MDR Report Key: 9603154
• MDR Text Key: 194177713
• Report Number: 9610617-2020-00004
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551077412
• UDI-Public: 4048551077412
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K943668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/15/2020

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
• Device Operator: Health Professional
• Device Model Number: 27050CA
• Device Catalogue Number: 27050C
• Device Lot Number: NU01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention