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

Model Number CB030

Device Problems Material Deformation (2976); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2022

Event Type  malfunction  

Event Description

Procedure performed: unknown.Event description: [institution] report from the sales rep when the scissors were inserted from the trocar, the scissors was stuck open in the abdominal cavity and would not return.The case was completed with the new one.Initial investigation report the event unit was returned to us and visually inspected.A part of the blade was shaved and burred.(pic.1) after removing the burrs, it could be opened and closed, although it was stuck.The units will be returned to amr for further evaluation.Admin# (b)(4).Products available for return: 1 package, 1 scissors.Patient status: no patient injury.Intervention: the case was completed with the new one.

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.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the customer¿s experience of the blades not closing as there was damage on the blades, indicating a burr was previously present on the blades.Based on the condition of the returned unit, it is likely that the reported event was cause by the blades interfering with one another, which likely created a burr that prevented the blades from closing.Attempts to close the blade likely resulted in the burr falling off, resulting in the damage observed on the blades.However, the root cause of the blade interference is unknown.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: unknown.Event description: [institution].Report from the sales rep.When the scissors were inserted from the trocar, the scissors was stuck open in the abdominal cavity and would not return.The case was completed with the new one.Initial investigation report: the event unit was returned to us and visually inspected.A part of the blade was shaved and burred.(pic.1) after removing the burrs, it could be opened and closed, although it was stuck.The units will be returned to amr for further evaluation.Admin# (b)(6).Products available for return: 1 package, 1 scissors.Patient status: no patient injury.Intervention: the case was completed with the new one.

• Brand Name: CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX
• Type of Device: 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: 16132549
• MDR Text Key: 308643101
• Report Number: 2027111-2023-00314
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)241019(30)01(10)1432833
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

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
• Device Operator: Health Professional
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1432833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1