MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOLLOW SHAFT-MOTOR ROTOCUT G2

Model Number 26720M

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The device in question is not registered or sold in the us, but a similar device is registered in the us.The event is filed under internal (b)(6) complaint id: (b)(4).

Event Description

The event occurred in germany.It was reported that the hollow shaft-motor rotocut g2 heated up.Patient was burned.Additional patient information is not available.

Manufacturer Narrative

The reported malfunction (device became hot and burned the patient's skin) couldn't be reproduced.The device wasn't available to be returned to karl storz tuttlingen.The available information was provided to the product management for evaluation.A malfunction or overload of the hollow shaft motor could not lead to such rapid heating of the product and cause the described effects on the patient.The motor control unit, which supplies the motor with energy, has an overload protection.In event of increased friction or resistance at the motor, the motor control unit detects a high current demand and peels off.Therefore, rapid heating due to excessive energy input is seen as unlikely.Heating due to prolonged use would lead at most to a slow heating of the product, which would be noticed by the user before it could lead to the described patient damage.Long-term use is influenced in particular by the tissue to be morcellated, but also by the use of an appropriately functioning knife, which here refers in particular to the sharpness of the cutting edge.However, based on the available information, we concluded user error as most common root cause.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOLLOW SHAFT-MOTOR ROTOCUT G2
• Type of Device: HOLLOW SHAFT-MOTOR
• 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: 16179903
• MDR Text Key: 307497208
• Report Number: 9610617-2023-00016
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551338582
• UDI-Public: 4048551338582
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

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 Operator: Health Professional
• Device Model Number: 26720M
• Device Catalogue Number: 26720M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/16/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other