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	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: design validation activities.Event description: jaws are a little tight.Feels like a 2 step process.Feels like they need to be oiled.Feedback provided by [name] during scissors design validation.Product is not available for return.Additional information received on 12may2023 via email from [name], clinical development analyst: complaint created based off feedback 5242.Submitted 22mar2023.Device was used on porcine tissue during design validation at viticus center.No issues completing testing.The device was functional upon initial use.The user was cutting stomach blood vessel when rough blade actuation was noticed.Patient status: device was used on porcine tissue.Intervention: no issues completing testing.
Additional Manufacturer Narrative
The event unit is not anticipated to return to applied medical.A follow up report will be provided upon completion of the investigation.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.The probability and criticality of the harm resulting from this event have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: design validation activities event description: jaws are a little tight.Feels like a 2 step process.Feels like they need to be oiled.Feedback provided by [name] during scissors design validation.Product is not available for return.Additional information received on 12may2023 via email from [name], clinical development analyst: complaint created based off feedback 5242.Submitted 22mar2023 device was used on porcine tissue during design validation at (b)(6) center.No issues completing testing.The device was functional upon initial use.The user was cutting stomach blood vessel when rough blade actuation was noticed.Patient status: device was used on porcine tissue.Intervention: no issues completing testing.

• 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: 17110164
• Report Number: 2027111-2023-00486
• Device Sequence Number: 2188262
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)250414(30)01(10)1451264
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: 04/14/2025
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1451264
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2022
• Supplement Date Received by Manufacturer: 05/22/2022
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2022
• 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
• Patient Sex: Unknown