MAUDE Adverse Event Report: KARL STORZ SE & CO. KG METAL OUTER SHEATH, INSULATED, 36 CM

Model Number	33300
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an emergency laparoscopic appendicectomy a small fragment of metal came off one of the black insulated tubes for a laparoscopic grasper mid procedure.A crack was heard, and a visible fragment of metal was seen to fly off onto the omentum.The grasper was removed and another device was used to remove the fragment of metal safely.It could visibly be seen that both small metal fragments that would normally sit at the shoulder of the instrument were missing.The procedure it was escalated, and a further fluoroscopy was taken.This led to prolonged anaesthesia.The fragment was retrieved by the surgeon, and it was confirmed by x-ray that there were no fragments left inside the patient due to the additional fluoroscopy and x-rays the event is deemed reportable.
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).
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
Device evaluation: the product was sent in and the investigation was performed on 2025-09-10: during evaluation of the instrument a break in the bayonet lock at the distal end was detected.This defect caused two small metal fragments to become detached, which normally serve to securely lock the working head in place.The break meant that the instrument was no longer functional.The insert could no longer be closed correctly, which meant that the working head did not open when the handle was operated, but was pushed out instead.The damage was caused by mechanical impact.In addition, the age of the instrument (manufactured in 2014, 11 years old) played a role: material fatigue and possible corrosion may have impaired its stability and affected the service life of the item.Therefore, it can be concluded that the break was due to wear.A careful functional and visual inspection before use, as recommended in the instructions for use, might have detected the defect at an early stage.This event is filed under internal complaint id (b)(4).

• Brand Name: METAL OUTER SHEATH, INSULATED, 36 CM
• Common Device Name: METAL OUTER SHEATH, INSULATED, 36 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 ave; el segundo, CA 90245
• MDR Report Key: 21978417
• Report Number: 9610617-2025-00805
• Device Sequence Number: 15270253
• Product Code: GCJ
• UDI-Device Identifier: 04048551002308
• UDI-Public: 04048551002308
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K935071
• 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): 09/19/2025

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: 33300
• Device Catalogue Number: 33300
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 05/16/2025; 09/10/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/27/2025; 09/19/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown