MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE METAL OUTER SHEATH

Model Number	33300M
Medical Device Problem Codes	Material Fragmentation (1261); Mechanical Problem (1384); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the clickline metal outer sheath tubes are very rigid which have caused breakage below the joint.
Additional Manufacturer Narrative
The device will 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).
Additional Manufacturer Narrative
Instrument broke during gastric bypass procedure; the surgeon informed the nurse circulating in the room that the instrument was broken.The nurse collected the broken pieces and she asked the reprocessing team leader nurse to note the equipment breakdown.All the pieces of the instrument have been recovered.There was a five-minute delay in the procedure.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
The affected device will be forwarded to the manufacturing site for investigation.Should relevant additional information.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Correction is provided in section g2.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
During the investigation, deviations in the adhesive bond and an unusual breakage point were identified.These anomalies indicate that the product was either used outside the intended specifications or handled improperly.The location of the break in the assembled state does not indicate a material or design defect but rather suggests external influences or tampering that are not part of the regular manufacturing process.The analysis did not reveal any indications of errors in connection with the labeling, the device itself, or its history.All production-related quality controls were passed successfully, and no deviations were found in the manufacturing records.The labeling was complete and contained all relevant instructions and warnings.An evaluation of the complaint history also revealed no accumulation of similar cases[?]no trend or systematic cause could be identified.The available findings rule out a production error.Rather, the results indicate improper handling or external influences by the user.This event is filed under internal complaint id_(b)(4).

• Brand Name: CLICKLINE METAL OUTER SHEATH
• Common Device Name: CLICKLINE METAL OUTER SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo ; 4242188247
• MDR Report Key: 21265993
• Report Number: 9610617-2025-00071
• Device Sequence Number: 3627580
• Product Code: GCJ
• UDI-Device Identifier: 04048551133965
• UDI-Public: 04048551133965
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/12/2025

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: 33300M
• Device Catalogue Number: 33300M
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 01/31/2025; Not provided; 05/07/2025; 08/07/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/04/2025; 04/21/2025; 05/08/2025; 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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