MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIVE S 3.5X65, STERILE, FOR SINGLE USE,

Model Number	091361-06
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was used and contaminated, and thus will not be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that during double-lumen placement procedure on (b)(6) 2024, the distal tip of the scope broke.No patient injury was reported, and they were able to complete the procedure using a back-up stethoscope.
Additional Manufacturer Narrative
Per investigation by the manufacturing site: as no product has been returned a final determination of the root cause is not possible.In similar cases with the same product, excessive force during application lead to damages at the endoscope.This event is filed under internal complaint id (b)(4).

• Brand Name: FIVE S 3.5X65, STERILE, FOR SINGLE USE,
• Common Device Name: FIVE S 3.5X65, STERILE, FOR SINGLE USE,
• 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 ; 4242188247
• MDR Report Key: 19697788
• Report Number: 9610617-2024-00199
• Device Sequence Number: 11687715
• Product Code: CAL
• UDI-Device Identifier: 04048551422519
• UDI-Public: 04048551422519
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: 091361-06
• Device Catalogue Number: 091361-06
• Device Lot Number: 500099740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown