MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER CERAMIC INSULATION TUBE; RESECTOSCOPE SHEATH, INNER FIXED SHEATH

Model Number 27040XA

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

The item is not returned.

Event Description

Allegedly, during a urology resection procedure, the tip of the sheath broke off and fell into the patient.The doctor successfully retrieved the piece(s) and confirmed with x-ray that nothing was left inside the patient.Procedure was completed with another sheath with no harm to the patient.

• Brand Name: INNER CERAMIC INSULATION TUBE
• Type of Device: RESECTOSCOPE SHEATH, INNER FIXED 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 ; 2188201
• MDR Report Key: 10497234
• MDR Text Key: 206349741
• Report Number: 9610617-2020-00096
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 4048551076521
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/04/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 27040XA
• Device Catalogue Number: 27040XA
• Device Lot Number: NR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention