MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RESECTOSCOPE SHAFT, 27 CHARR

Model Number 27241AO

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2022

Event Type  malfunction  

Manufacturer Narrative

The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.

Event Description

The reported event occurred in germany.During a case, the ceramic tip broke off inside the patient.The fragment could be retrieved.The case could be completed with another instrument.No injury to a patient, user, or third was reported.Internal karl storz reference number: (b)(4).

Manufacturer Narrative

Upon evaluation, the breakage could be confirmed.The most probable root cause is that after 12 years micro cracks have formed which have weakened the beak, and after this time it has broken during use due to the resulting forces.In the ifu it is pointed out that the ceramic beak must be checked for damage before the operation and replaced if necessary.Internal karl storz reference number: (b)(4).

• Brand Name: RESECTOSCOPE SHAFT, 27 CHARR
• Type of Device: RESECTOSCOPE SHAFT, 27 CHARR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15860875
• MDR Text Key: 305901358
• Report Number: 9610617-2022-00313
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K943668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

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 Model Number: 27241AO
• Device Catalogue Number: 27241AO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 11/24/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2010
• 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