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

Model Number C4130

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/12/2021

Event Type  malfunction  

Manufacturer Narrative

The event unit is not being returned to applied medical for evaluation but lot number is provided.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed: unsure detailed description of event: as per attached form filled out by nurse attending, part of the device came off in patient.Quality report form from hospital states that small piece detached from grasper tip.Patient status: no adverse event for patient.Type of intervention: surgeon had to locate the lost piece from abdomen - no complications.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.However, photographs of the event unit and the detached piece were provided, confirming the complainant¿s experience of pad detachment.Based on similar events, it is likely that the reported event was caused by adhesive failure.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Name of procedure being performed: unsure.Detailed description of event: as per attached form filled out by nurse attending, part of the device came off in patient.Quality report form from hospital states that small piece detached from grasper tip.Patient status: no adverse event for patient.Type of intervention: surgeon had to locate the lost piece from abdomen - no complications.

• 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 12929608
• MDR Text Key: 286366889
• Report Number: 2027111-2021-00754
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)240520(30)01(10)1417785
• 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
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

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 Expiration Date: 05/20/2024
• Device Model Number: C4130
• Device Catalogue Number: 101419801
• Device Lot Number: 1417785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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