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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

The ceramic tip fractured/broke from the sheath.

Event Description

Allegedly, during completion of a turp procedure, some piece 's' of the ceramic tip of the sheath were discovered in the outflow bag.The doctor retrieved the piece's' from the collection bag, no harm to the patient; and no other surgical intervention required, procedure was completed.

• 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 90245 ; 4242188201
• MDR Report Key: 10546226
• MDR Text Key: 209223821
• Report Number: 9610617-2020-00104
• 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: 09/15/2020

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: OP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2020
• 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
• Patient Age: 60 YR
• Patient Weight: 82