MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CANNULA SUCTION & COAGULATION

Model Number	37370DL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not yet been received by the factory.
Event or Problem Description
As per a manufacture incident report we received from the factory in (b)(4) which was filed with the (b)(4): during the operation, the hook detached from the hook electrode and could no longer be found in the patient.
Additional Manufacturer Narrative
Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 6.According to information received on 30th nov.2020, the device was requested several times and is deemed as unattainable by the hospital.Therefore no product investigation can be executed.The complaint data was reviewed for similar cases, no indication for a systematic issue was found.No product for investigation received.Former cases with similar failure description were damaged or overloaded by user.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: CANNULA SUCTION & COAGULATION
• Common Device Name: CANNULA SUCTION & COAGULATION
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245 ; 2188201
• MDR Report Key: 10323250
• Report Number: 9610617-2020-00085
• Device Sequence Number: 11529425
• Product Code: KNF
• UDI-Device Identifier: 04048551155653
• UDI-Public: 4048551155653
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K944862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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: 37370DL
• Device Catalogue Number: 37370DL
• Device Lot Number: OQ02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2019
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown