MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4140, 5MMX45CM EPIX LAPA GRASPER, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4140
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
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: laparoscopic colostomy takedown with anastomosis.Green plastic located on shaft broke off and fell into the patient during case.The area that broke off was about 1 cm into the green plastic portion distal to the tip of the device.Surgeon was able to retrieve all plastic pieces.No patient injury occurred.Product is available for return.Intervention: surgeon was able to retrieve all plastic pieces.Patient status: no patient injury occurred.
Event or Problem Description
Procedure performed: laparoscopic colostomy takedown with anastomosis event description: green plastic located on shaft broke off and fell into the patient during case.The area that broke off was about 1 cm into the green plastic portion distal to the tip of the device.Surgeon was able to retrieve all plastic pieces.No patient injury occurred.Product is available for return.Additional information received on 13oct2022 via email from [name], account manager: hospital discarded the product.Intervention: surgeon was able to retrieve all plastic pieces.Patient status: no patient injury occurred.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, photos of the event unit were provided, which confirmed the complainant¿s experience of shaft damage.Based on the photos provided, it is likely that the reported event was caused by a large force applied to the device.The probability and criticality of the harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: C4140, 5MMX45CM EPIX LAPA GRASPER, 10/BX
• Common Device Name: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• 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: 15545219
• Report Number: 2027111-2022-00764
• Device Sequence Number: 5862004
• Product Code: NWV
• UDI-Device Identifier: 00607915110154
• UDI-Public: (01)00607915110154(17)250424(30)01(10)1450479
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 12/08/2022

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: 04/24/2025
• Device Model Number: C4140
• Device Catalogue Number: 101475847
• Device Lot Number: 1450479
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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