MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Model Number	CB030
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: hysteromyomectomy.Event description: [user facility] "surgeon connect this unit to esu but it is not energized.They try to change the cable and equipment.This unit is still not working." expect product return.Additional information was received via email on 20oct2022 from [name], purchasing representative, [distributor] the cautery function doesn't work.A [competitor] monopolar cord was used.The cord was able to be attached to the device.The cable was replaced with an alternate device.This did not provide a resolution.There are no pictures available.No other instruments were used during the procedure.Patient status: "fine." intervention: "they try to change the cable and equipment.This unit is still not working.".
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed as the unit functioned as intended.The event unit met current specifications and there were no visible non-conformances.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: hysteromyomectomy.Event description: [user facility] "surgeon connect this unit to esu but it is not energized.They try to change the cable and equipment.This unit is still not working." expect product return.Additional information was received via email on 20oct2022 from [name], purchasing representative, [distributor].The cautery function doesn't work.A [competitor] monopolar cord was used.The cord was able to be attached to the device.The cable was replaced with an alternate device.This did not provide a resolution.There are no pictures available.No other instruments were used during the procedure.Patient status: "fine" intervention: "they try to change the cable and equipment.This unit is still not working.".

• Brand Name: CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX
• Common Device Name: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15715287
• Report Number: 2027111-2022-00806
• Device Sequence Number: 12426269
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)250807(30)01(10)1460353
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K062169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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 Expiration Date: 08/07/2025
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1460353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ESU
• Patient Sex: Unknown