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

Model Number C4130

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.

Event Description

Procedure performed: laparoscopic appendectomy.Lap appendectomy procedure using c4130.A piece of plastic material broke off when the grasper was inserted into the patient, identified straight away, retrieved all broken pieces, matched up with placing back the broken parts onto the grasper.Patient status: patient did not incur injury.Type of intervention: retrieved broken pieces.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of shaft damage.Based on the condition of the returned unit, it is likely that the shaft damage resulted from a large side load that was applied to the distal end of the device during use.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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.

Event Description

Procedure performed: laparoscopic appendectomy.Lap appendectomy procedure using c4130.A piece of plastic material broke off when the grasper was inserted into the patient, identified straight away, retrieved all broken pieces, matched up with placing back the broken parts onto the grasper.Patient status: patient did not incur injury.Type of intervention: retrieved broken pieces.

• Brand Name: C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX
• Type of Device: NWV
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8565802
• MDR Text Key: 143950127
• Report Number: 2027111-2019-00439
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)211129(30)01(10)1341855
• 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: 05/29/2019

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: 11/29/2021
• Device Model Number: C4130
• Device Catalogue Number: 101419801
• Device Lot Number: 1341855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 05/30/2019
• Patient Sequence Number: 1