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

Model Number 37370DL

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

Device has not yet been received by the factory.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 209222905
• Report Number: 9610617-2020-00085
• Device Sequence Number: 1
• Product Code: KNF
• UDI-Device Identifier: 04048551155653
• UDI-Public: 4048551155653
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K944862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other