MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SILGRASP GRASPING FORCEPS

Model Number	28171HBN
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
According to the information received, broke during use.No negative impact in state of health reported.
Additional Manufacturer Narrative
The above conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production related quality checks were passed and no non-conformities were identified in the devices manufacturing records.The returned instrument (storz forceps, manufactured in 2016) showed a fracture on the lower fixed jaw.The examination revealed severe wear on the teeth and corrosion on the mating surfaces.The product had been in use for around 9 years and was therefore probably beyond its recommended life cycle.The analysis shows that the fracture was most likely caused by a combination of material fatigue (age), corrosion due to repeated reprocessing, and possible mechanical overload.Microcracks caused by corrosion may have further contributed to the fracture.The breakage is not attributable to a single defect, but to the cumulative effect of age, corrosion, and stressing conjunction with possible user error due to insufficient monitoring and exceeding the recommended service life.The ifu expressly points out the need for regular inspections and the effects of repeated reprocessing on service life.The traces of corrosion found and the extended use beyond the recommended service life indicate that these specifications were not fully complied with.The complaint history did not reveal any pickup in similar complaints, no trend was identified the event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: SILGRASP GRASPING FORCEPS
• Common Device Name: SILGRASP GRASPING FORCEPS
• 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: 22087457
• Report Number: 9610617-2025-00918
• Device Sequence Number: 8060162
• Product Code: LXH
• UDI-Device Identifier: 04048551322147
• UDI-Public: 04048551322147
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 05/06/2026

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: 28171HBN
• Device Catalogue Number: 28171HBN
• Device Lot Number: OT02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 05/06/2026
• 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