MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CANNULA SUCTION & COAGULATION

Model Number	37370DL
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The event occurred in china: it was reported that the hook was broken during surgery.The broken part fell into the patient's body but could successfully be retrieved.No harm to patient, user or third reported.Internal karl storz reference number: (b)(4).
Additional Manufacturer Narrative
The article 37370dl was probably subjected to too much force, which caused the hook to break at the distal end.Since the rest of the hook is still in the instrument and the weld is not damaged, a possible cause is that the hook was overloaded, causing it to bend and beyond which led to the breakage.By reviewing the similar complaint there is no indication for an increase/ trend of the reported issue.Internal karl storz reference number: (b)(4).
Additional Manufacturer Narrative
This supplemental report is to correct the date in section b4 to reflect the accurate date in which the first supplemental report was submitted on january 5, 2023.Internal karl storz reference number: (b)(4).
Additional Manufacturer Narrative
Correction in section h-1 to maulfunction.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CANNULA SUCTION & COAGULATION
• Common Device Name: CANNULA SUCTION & COAGULATION
• 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: 15735415
• Report Number: 9610617-2022-00300
• Device Sequence Number: 6316641
• Product Code: KNF
• UDI-Device Identifier: 04048551155653
• UDI-Public: 4048551155653
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K944862
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 37370DL
• Device Catalogue Number: 37370DL
• Device Lot Number: YO02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 12/14/2022; 12/14/2022; 03/19/2025
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/05/2023; 01/09/2023; 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown