MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RHINOFORCE II NASENZANGE, 90°, GR.2; SOFT TISSUE FORCEPS, SCISSOR-LIKE, REUSABLE

Model Number	456802B
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The item in question was sent to the manufacturer on 2022-07-22.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.
Event or Problem Description
As per a manufacturer incident report #(b)(4) received from the factory in germany: the event occurred in germany.During procedure, the jaw came off and was swallowed by the patient.The fragment was visible on x-ray, but after a new x-ray, it was not visible anymore.Therefore, it is unclear if the fragment remained in the patient's body or not.

• Brand Name: RHINOFORCE II NASENZANGE, 90°, GR.2
• Common Device Name: SOFT TISSUE FORCEPS, SCISSOR-LIKE, REUSABLE
• 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 avenue; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15164664
• Report Number: 9610617-2022-00135
• Device Sequence Number: 4730306
• Product Code: LRC
• UDI-Device Identifier: 04048551164372
• UDI-Public: 04048551164372
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2022

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: 456802B
• Device Catalogue Number: 456802B
• Device Lot Number: BD2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2006
• 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: Other
• Patient Sex: Unknown