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	03/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: tlh.Event description: facility: [user facility] hospital.Subject of complaint: the blade opening was very poor.This is a complaint from the market.Administrative (b)(4).Please refer to the complaint sheet for investigation.Report from the sales rep the blade opening was very poor during the procedure.The case was completed with the new one.Initial investigation report the event unit was returned to us and visually inspected.When the handle was opened, the blade tips appeared to be crossed and in excessive contact (pic.1) the units will be returned to amr for further evaluation.Admin# (b)(4).Components available for return: 1 package, 1 scissors.Intervention: the case was completed with the new one.Patient status: no patient injury.
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: tlh.Event description: facility: [user facility] hospital.Subject of complaint: the blade opening was very poor this is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation.Report from the sales rep.The blade opening was very poor during the procedure.The case was completed with the new one.Initial investigation report.The event unit was returned to us and visually inspected.When the handle was opened, the blade tips appeared to be crossed and in excessive contact (pic.1) the units will be returned to amr for further evaluation.Admin# (b)(4).Components available for return: 1 package, 1 scissors.Intervention: the case was completed with the new one.Patient status: no patient injury.
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, as the event unit passed all relevant testing and met current specifications.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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: 14479515
• Report Number: 2027111-2022-00606
• Device Sequence Number: 5160410
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)240805(30)01(10)1425762
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

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: 08/05/2024
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1425762
• 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: 05/09/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• 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