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

Model Number CB030

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed: na (before use).Detailed description of event: consumable was contaminated as there was a break of sterility by another consumable that was placed on top of it and the sterile field.Consumable not used on patient.No clinical impact to the patient as a result of the event.Open another pack to resolve the situation.Type of intervention: na (before use).Patient status: na (before use).

Event Description

Name of procedure being performed: na (before use).Detailed description of event: consumable was contaminated as there was a break of sterility by another consumable that was placed on top of it and the sterile field.Consumable not used on patient.No clinical impact to the patient as a result of the event.Open another pack to resolve the situation.Type of intervention: open another pack.Patient status: no clinical impact to the patient.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation with no inner packaging.As the inner packaging was not returned, the complainant¿s experience of a sterility break is unable to be confirmed.Applied medical is unable to determine if the inner packaging exhibited any non-conformances that could have contributed to the reported event.In the absence of the inner packaging, 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 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
• Type of Device: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17996353
• MDR Text Key: 326390708
• Report Number: 2027111-2023-00662
• Device Sequence Number: 1
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)260310(30)01(10)1483234
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K062169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• 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: 1483234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2023
• 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