MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE FORCEPS OUTER SHEATH, INSULATED; METAL OUTER SHAFT, INSULATED

Model Number	33500
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(4): during operation, the surgeon felt that the handle of the tenaculum forceps was not moving smoothly.Thus, he asked the nurse to separate the insert with the handle.The outer sheath 33500 was then found broken and was snapped at the proximal end.The surgeon tried to retrieve all the broken parts of the outer sheath.For the case on (b)(6), the surgeon could not find all the detached parts.Since some of the detached parts for the case on (b)(6) were not found, there could be a risk due to foreign body left in patient.According to our information, no additional hospitalization was necessary.There is not yet enough information available to classify the health impact or if any occured.(mfr's.Internal complaint # (b)(4)).
Additional Manufacturer Narrative
The affected article has been requested for investigation by the manufacturer and is in transit to the manufacturing site in (b)(4).
Additional Manufacturer Narrative
The affected article was investigated by the manufacturer.Upon investigation it could be confirmed that the product has broken at the metal connecting piece on the proximal end.Based on the defect pattern found on the product, it can be assumed that too much force must have been applied to cause this breakage.And this breakage caused that the forceps to not move smoothly anymore.
Additional Manufacturer Narrative
As per further information received by the manufacturer on feb 16,2022: it was initially reported that the surgeon tried to retrieve all broken parts but could not find all the detached parts.However, further information has been received from the hospital indicating that the broken part was possibly swept away by staff as debris unintentionally.Furthermore, it was stated that they checked thoroughly on the surgery location, and there was no suspected subjects or abnormality.Based on this newly received information, and the risk analysis corresponding to the concerned product, it is concluded that the event did not, and might not, lead to death or serious deterioration in the state of health if it were to recur.Consequently, the event is rated as not reportable.The evaluation of the device has not been concluded as of yet.

• Brand Name: CLICKLINE FORCEPS OUTER SHEATH, INSULATED
• Common Device Name: METAL OUTER SHAFT, INSULATED
• 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 ; 13803 n. promenade blvd.; stafford, TX 77477
• MDR Report Key: 13444222
• Report Number: 9610617-2022-00017
• Device Sequence Number: 4321636
• Product Code: GCJ
• UDI-Device Identifier: 04048551150931
• UDI-Public: 4048551150931
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2022

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: 33500
• Device Catalogue Number: 33500
• Device Lot Number: RT05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 02/16/2022; 03/18/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/11/2022; 03/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2016
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown