MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE OUTER SHEATH/ FORCEPS INSERT; SHEATH FOR RIGID ENDOSCOPE

Model Number	30310MDS
Medical Device Problem Codes	Scratched Material (3020); Insufficient Device Problem Information (3190); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): according to the received information, when trying to pull out the forceps (art.30310mds), some resistance was felt.After that, it was found that a part of the outer sheath material was damaged.The part of the damaged material was not found yet.It was stated that at present, the patient is in good condition.Based on the information available so far, there could be a risk of a foreign body left in the patient.So, there is not yet enough information available to classify the health impact or if any occurred.(mfr's.Internal complaint (b)(4)).
Additional Manufacturer Narrative
On 17th march 2022 photos of the affected product were received and the manufacturer was informed that the product has been discarded by the customer.The product could, therefore, not be returned to the manufacturer and the investigation could only be based on the received information and photos.The photos show that there are damages (e.G.Scratches) on the insulation of the outer sheath of the forceps insert.Based on the visible damages and the received incident description, it can be assumed that the damage to the insulation potentially happened when the instrument was pulled out by the user during the surgery.Since the product has already been discarded, the damage could not be inspected in more detail.Based on the age of the product, it could also be possible that there had been wear and tear to the sheath before.In the corresponding ifu of the product the risk of a damaged insulation is pointed out and it is stated to check all articles for function and damages immediately before and after every use and to withdraw damaged devices from use.
Event or Problem Description
Further information received: no residual capsules or other residues were found in the patient's body, and the surgery was completed as scheduled.

• Brand Name: CLICKLINE OUTER SHEATH/ FORCEPS INSERT
• 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: 13625182
• Report Number: 9610617-2022-00019
• Device Sequence Number: 17452128
• Product Code: GCJ
• UDI-Device Identifier: 04048551121771
• UDI-Public: 4048551121771
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/12/2022

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: UW04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2013
• 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