MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE OUTER SHEATH/ FORCEPS INSERT (KELLY DISSECTING AND GRASPING FORCEPS); SHEATH FOR RIGID ENDOSCOPE

Model Number	30310MDS
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): paediatric consultant surgeon was doing thoracic oesophageal duplication cyst resection via thoracotomy approach during surgery.Surgeon was using forceps kelly dissecting & grasping 3mm.Somehow, when surgeon tred to take forceps kelly out, it was not coming through 3mm trocar.So surgeon made an incision bigger and removed the forceps.When the forceps out, scrub nurse noticed screw is missing from the forceps and informed the surgeon.Did x-ray to patient, nothing found.The patient condition post-op was okay.(mfr's.Internal complaint #(b)(4)).
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.
Additional Manufacturer Narrative
Per manufacturer's evaluation finding: the affected 30310mds forceps insert has been inspected by the manufacturer.Upon the investigation it could be confirmed that one rivet on the joint/hinge of the forceps is broken.Based on the breaking point visible on the rivet, which shows an even fracture, it an be concluded that there must have been a large shear effect/ mechanical overload exerted on the rivet to cause the breakage.A mechanical overload by too much force application is, therefore, determined as the most probable root cause.In addition, the affected article was produced in june 2012, so it can be assumed that there has been some wear coming from many applications.The applicable instruction manual for the product includes the following safety relevant information: "warning: risk of injury: overloading the instrument by exerting too much force may cause the medical device to break, bend, and malfunction, and consequently injure the patient or user.Do not overload the instruments.Do not bend bent instruments back to their original position."."warning: risk of injury: incorretly assembled and damaged instruments can lead to injuries to the patient.Instruments and all of the accessories used in combination with them must be checked immediately before and after every use to ensure that they are complete, free from damage, and in full working order and have no unintentional rough surfaces, sharp corners, burred edges or projecting parts.Care must be taken not to leave missing or broken-off components inside the patient.".

• Brand Name: CLICKLINE OUTER SHEATH/ FORCEPS INSERT (KELLY DISSECTING AND GRASPING FORCEPS)
• Common Device Name: SHEATH FOR RIGID ENDOSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 13869693
• Report Number: 9610617-2022-00029
• Device Sequence Number: 4715904
• Product Code: GCJ
• UDI-Device Identifier: 04048551121771
• UDI-Public: 4048551121771
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2022

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: 30310MDS
• Device Catalogue Number: 30310MDS
• Device Lot Number: TX04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2012
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 2 KG