MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SNAP IN HIGH FLOW SHEATH; ARTHROSCOPY HIGH FLOW SHEATH

Model Number	28136CR
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distal tip is gouged.Corrosion was found at the stopcock holes.The lot code is from 2016.This could indicate wear and tear of the product.Ifu suggestion of the end of the product's lifespan " limits of reprocessing" is " largely determined by wear and chemicals used".
Event or Problem Description
During a procedure the doctor reported the edges of the instrument being jagged and cutting/eating the tissue.No further information was reported by the facility regarding the patient.

• Brand Name: SNAP IN HIGH FLOW SHEATH
• Common Device Name: ARTHROSCOPY HIGH FLOW SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo
• MDR Report Key: 15370615
• Report Number: 9610617-2022-00260
• Device Sequence Number: 11168515
• Product Code: HRX
• UDI-Device Identifier: 04048551234242
• UDI-Public: 4048551234242
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K963524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2022

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: 28136CR
• Device Catalogue Number: 28136CR
• Device Lot Number: UT01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown