MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 4 MM, 18 CM

Model Number	28731BWA
Medical Device Problem Codes	Material Separation (1562); Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported: "the telescope was inserted into a patients shoulder for an arthroscopy, the image was previously fine and in working order, but on insertion the screen suddenly became dark and occluded, the scope was removed and examined and appeared to be chipped at the insertion end.This was removed from the patient and replaced with another that was working.The small piece of metal was identified inside the wound and removed with arthroscopic suction." no negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.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
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
Result of investigation: the information provided by the customer "sealant around distal lens dislogged" can be confirmed.The distal soldered seam is severely chemically attacked and therefore leaking.There is an unknown whitish coating on the distal cover glass, which impairs and clouds the imaging.The leaky solder seam allows liquid to enter the rod lens system unhindered, which impairs imaging in addition to the existing coating on the cover glass.According to the customer, an unknown object was recovered from the surgical wound but could not be described in more detail due to its minimal size.The damage found cannot be attributed to a manufacturing/production defect.It is possible that the chemical damage to the distal soldering suture was caused by incorrect / improper clinical reprocessing, reprocessing medium, reprocessing duration.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 30°, 4 MM, 18 CM
• Common Device Name: HOPKINS TELESCOPE 30°, 4 MM, 18 CM
• 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: 21632999
• Report Number: 9610617-2025-00453
• Device Sequence Number: 9246157
• Product Code: HRX
• UDI-Device Identifier: 04048551115152
• UDI-Public: 04048551115152
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K943052
• 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
• Report Date (Section B): 10/06/2025

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: 28731BWA
• Device Catalogue Number: 28731BWA
• Device Lot Number: 1242FB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 09/23/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/17/2025; 10/06/2025
• 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