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

Model Number C4130

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Procedure performed: "lap sigmoid".Event description: "the tip of the grasper fell into a patient." additional information was received via email from account manager on march 9, 2018: "they aren't sure when it happened, they just saw it out on the table after." additional information was received via telephone from account manager march 12, 2018: "the surgeon and scrub tech stated that there were no complications.It was a straightforward case.They removed the grasper and laid it down on the patient and when they went to grab the grasper they noticed the tip fell off the grasper and was on the patient.The tip fell off outside of the patient.They did not have to fish it out from inside the patient.They are not sure what happened." type of intervention: unk.Patient status: "patient was not affected by this incident and is doing fine.".

Manufacturer Narrative

Investigation summary: the event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of pad detachment.Based on the condition of the returned unit, it is likely that the reported event was caused by a lack of adhesion due to improper bonding of the pad to the jaw.The probability and criticality of harm resulting from this failure mode 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.

• 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
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 7405398
• MDR Text Key: 105249213
• Report Number: 2027111-2018-00139
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)201115(30)01(10)1311274
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

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: Other
• Device Expiration Date: 11/15/2020
• Device Model Number: C4130
• Device Catalogue Number: 101419801
• Device Lot Number: 1311274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 04/06/2018
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1