MAUDE Adverse Event Report: TROKAMED GMBH GRIP MODUL V2.0, 5-TIMES-USE MORCELLATOR SYSTEM

Model Number	02-33117
Medical Device Problem Code	Failure to Shut Off (2939)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The problem was reported to us via customer complaint (b)(4) on (b)(6) 2023: when using the morcellator, the cutting module continued to rotate even though the activation switch of the handle module was released by the user.The ub-20230501_morcellator_schalter investigation report was prepared to analyze the cause.The cause of the error pattern was found to be a faulty switch function, i.E.The contact distances of the switch may be too small.The seat of the fixing screw of the activation switch in the grip module was tested with an unsuitable testing device.As a result, products with too small a switch contact distance (contact screw to spring plate) have come into circulation.With these products, it is therefore possible that the grip module transmits an "on" signal to the control unit even after the activation switch has been released and that the cutting module continues to rotate even after the activation switch has been released.Reason for fsca: urgent safety information is being issued to reduce the risk of the occurrence of a significant delay in the medical procedure if a user has to make an unplanned change from hand to foot control during a procedure due to the sudden problem described.To date, we have not received any reports of patient harm resulting from the issue described.After testing and evaluation of the product, the internal vigilance procedure started at the beginning of june.

• Brand Name: GRIP MODUL V2.0, 5-TIMES-USE MORCELLATOR SYSTEM
• Common Device Name: MORCELLATOR SYSTEM
• Manufacturer (Section D): TROKAMED GMBH; kleine breite 17; geisingen, 78287 ; GM 78287
• Manufacturer (Section G): TROKAMED GMBH; keline breite 17; geisingen, 78187 ; GM 78187
• Manufacturer Contact: karl-heinz troendle ; keline breite 17; geisingen, 78187 ; GM 78187
• MDR Report Key: 18265377
• Report Number: 3004595684-2023-00003
• Device Sequence Number: 12735175
• Product Code: HET
• UDI-Device Identifier: 04251303811435
• UDI-Public: 04251303811435
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K091010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/21/2023

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: 02-33117
• Device Catalogue Number: 02-33117
• Device Lot Number: 154195
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown