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

Model Number C4140

Device Problem Material Fragmentation (1261)

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

Event Date 09/15/2022

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 303262960
• Report Number: 2027111-2022-00764
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915110154
• UDI-Public: (01)00607915110154(17)250424(30)01(10)1450479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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