MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4120, 38CM GRASPER REPOS CART, 10/BX; NWV

Model Number C4120

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Procedure performed: laparoscopic hiatus hernia repair.The head of the grasper came off into the patient.Territory manager has contacted nurse multiple times but only given limited information.Additional information received from territory manager on (b)(6) 2018: she was not too sure about the case but think it was a laparoscopic hiatus hernia repair with doctor.I don't have the lot no.As it was with the damaged atrac insert in an office along with the bit broken off.Territory manager has advised the packaging and product was collected at hospital and being returned enclosed in a biohazard bag.Patient status: unknown.Type of intervention: unknown.

Event Description

Procedure performed: laparoscopic hiatus hernia repair.The head of the grasper came off into the patient.Territory manager has contacted nurse multiple times but only given limited information.Additional information received from territory manager on 27 sept 2018: she was not to sure about the case but think it was a laparoscopic hiatus hernia repair with doctor.I don't have the lot no.As it was with the damaged atrac insert in an office along with the bit broken off.Territory manager has advised the packaging and product was collected at hospital and being returned enclosed in a biohazard bag.Additional information received via email on 24oct2018 from applied medical qc: the returned product was c4120 lot # 1326287.Patient status: unknown.Type of intervention: unknown.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation with the detached pad.Visual inspection confirmed the complainant¿s experience of pad detachment.The jaw had remnants of adhesive and fragments of the pad.Based on the condition of the returned unit, it is likely that the pad detachment resulted from being subject to a large amount of force during use.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance and safety of its products.

• Brand Name: C4120, 38CM GRASPER REPOS CART, 10/BX
• Type of Device: NWV
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7976215
• MDR Text Key: 124829192
• Report Number: 2027111-2018-00391
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

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: 05/17/2021
• Device Model Number: C4120
• Device Catalogue Number: 100864001
• Device Lot Number: 1326287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/17/2018
• Supplement Dates Manufacturer Received: 09/20/2018
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1