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

Model Number	38600
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Information recived by karl storz indicates that the device's sheath was seen to have a small section missing on the tip and it was not known if it was inside the patient.There was no way to know if the missing piece was missing before procedure.
Additional Manufacturer Narrative
As per a manufacturer incident report #(b)(4) recived from the factory in germany.The investigation is pending.
Additional Manufacturer Narrative
The affected 38600 robi metal outer sheath was returned to the manufacturer on 2022-08-25 and the investigation was finished on (b)(6) 2022.Upon inspection of the sheath, it could be confirmed that a small piece has broken off from the sheath surface at the distal end.There is also another crack visible on the surface, but no piece has broken off here.Based on the damages found on the sheath, it is concluded that the most probable root cause was an overload during use or reprocessing.The following safety-relevant information is stated in the corresponding ifu of the product: "3.3 correct handling > check the product for the following points before and after every use: - completeness - good working order - rough surfaces left inadvertently - sharp corners - burred edges - correct assembly of the components - functionality > do not leave broken-off components inside the patient.> do not overload the product with mechanical stress.3.4 damaged products damaged products can result in injury to patients, users or third parties.> before each use, check all components of the product for damage.> do not use damaged products.".
Event or Problem Description
The manufacturer's reference number for this case is (b)(4).

• Brand Name: ROBI OUTER SHEATH
• Common Device Name: ROBI METAL OUTER SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15324428
• Report Number: 9610617-2022-00253
• Device Sequence Number: 5888407
• Product Code: GEI
• UDI-Device Identifier: 04048551328606
• UDI-Public: 4048551328606
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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
• Device Model Number: 38600
• Device Catalogue Number: 38600
• Device Lot Number: ZS01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Death; Other
• Patient Sex: Unknown