MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CANNULA WITHOUT VALVE

Model Number	30160H1
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the black ring has fallen off.No negative impact in state of health reported.
Additional Manufacturer Narrative
An incorrect address was provided in section g1 in the initial report.This supplemental report is to provide the correct contact information for this section.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information: the affected items have not yet been returned for further investigation.Without the physical return of the defective products, a precise analysis of the cause is not possible.An inspection of the affected batches did not reveal any abnormalities or a recurrence of similar problems.According to the failure description, the defect affects the black id ring on the shaft of the cannula.Possible causes for the detachment or breakage of this ring could be: material fatigue due to aggressive processing: improper or excessive cleaning or disinfection can lead to premature aging of the material, causing the plastic to become brittle.· mechanical impact: an impact or blow could have caused the ring to break.· incorrect operation or improper handling: use that does not comply with the specifications may also cause the defect.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Product was evaluated on oct.20, 2025.Investigation: the items have now been returned so that an investigation could be carried out.A review of the affected batches revealed no abnormalities or recurrences of similar problems.Only one comparable isolated case was documented three years ago - in this case, the plastic marking ring was also broken.As can be seen on the returned items, the defect affects the black id ring on the shaft of the cannula.Possible causes for this ring coming loose or breaking could be: material fatigue due to aggressive processing: improper or excessive cleaning or disinfection can lead to premature aging of the material, causing the plastic to become brittle.Mechanical impact: an impact or blow could have caused the ring to break.Incorrect operation or improper handling: use that does not comply with the specifications can also lead to the defect.Conclusion: within twelve months, the black plastic ring (id ring) came loose on three different type 30160h1 cannulas at the customer's premises.This could indicate material fatigue due to aggressive cleaning, mechanical impact, or improper handling.An inspection of the returned products as well a review of the production batches revealed no systematic errors.The product return date was originally reported under a cross-referenced case · (b)(4).A supplemental report to reflect the product return date was accidendlty ommited.Therefore, this evaluation report has the aware date of aug.18, 2025.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CANNULA WITHOUT VALVE
• Common Device Name: CANNULA WITHOUT VALVE
• 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 avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21632997
• Report Number: 9610617-2025-00451
• Device Sequence Number: 13073000
• Product Code: GCJ
• UDI-Device Identifier: 04048551120835
• UDI-Public: 04048551120835
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K940347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/27/2025

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
• Operator of Device: Health Professional
• Device Model Number: 30160H1
• Device Catalogue Number: 30160H1
• Device Lot Number: ZM03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 08/01/2025; 08/18/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/17/2025; 08/12/2025; 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown