MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number C4130

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 10/12/2023

Event Type  malfunction  

Event Description

Name of procedure being performed: na (before use) detailed description of event 13-oct-2023 - complaint product family: grasper, product name: epix grasper, model number: c4130, lot number: 1468046.- the event occurred before use of the device, for an unknown procedure.- the nurse had identified whilst doing set-up.It was reported that hair had been found inside the sealed package of the device.- there was no clinical impact to the patient as a result of before use of the procedure.- the user resolved the situation by using another device from the shelf.- no other instruments were used when the complaint event occurred.Patient status: na (no patient involvement) type of intervention: na (before use).

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 13-oct-2023.Complaint product family: grasper, product name: epix grasper, model number: c4130, lot number: 1468046.The event occurred before use of the device, for an unknown procedure.The nurse had identified whilst doing set-up.It was reported that hair had been found inside the sealed package of the device.There was no clinical impact to the patient as a result of before use of the procedure.The user resolved the situation by using another device from the shelf.No other instruments were used when the complaint event occurred.Patient status: na (no patient involvement).Type of intervention: na (before use).

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of hair inside the sterile unopened pouch.Based on the condition of the returned unit and the description of the event, the hair likely originated from an operator during the manufacturing process.

• Brand Name: C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• 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: 18107291
• MDR Text Key: 328965999
• Report Number: 2027111-2023-00713
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)251103(30)01(10)1468046
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

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: C4130
• Device Catalogue Number: 101419801
• Device Lot Number: 1468046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2022
• 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