MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ARTICULATED STAND, L-SHAPED, LONG

Model Number	28272HC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that equipment broke the second time it was used.The broken pieces almost fell inside the patient during the procedure.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device 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.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: during inspection of the returned product two clamping jaws were found broken off inside.This is likely to be due to user error.The clamping jaws inside can break if the pin is not fully inserted into the counterpart (as described in the ifu).The ends of the clamping jaws rest on the larger diameter of the pin (they should fit into the area with the smaller diameter).Turning/tightening the clamping jaws thus exerts increased force on the jaws, causing them to break.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ARTICULATED STAND, L-SHAPED, LONG
• Common Device Name: ARTICULATED STAND
• 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
• MDR Report Key: 21242214
• Report Number: 9610617-2025-00059
• Device Sequence Number: 15579624
• Product Code: OCV
• UDI-Device Identifier: 04048551111048
• UDI-Public: 04048551111048
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K990334
• 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
• Report Date (Section B): 05/19/2025

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: 28272HC
• Device Catalogue Number: 28272HC
• Device Lot Number: UM01
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 05/12/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 05/05/2025; 05/19/2025
• 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