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

Model Number C4130

Device Problem Entrapment of Device (1212)

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

Event Type  malfunction  

Manufacturer Narrative

Full udi unknown as no lot number was provided no product is being returned for evaluation and no lot # has been provided to manufacturer.A follow-up report will be sent once the results have been analyzed.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.

Event Description

Lap cholecystectomy- "applied were contacted some time after the incident.The hospital/consultant have not reported this through (b)(4) as it did not cause unnecessary injury to the patient.The consultant wanted to make us aware of the issue for future reference.Tissue caught in the jaws of the device.I will meet with the surgeon later this week to get more detail if possible." intervention - "unknown." patient status - "unknown." date of event: (b)(6) 2015.

Manufacturer Narrative

Update - received additional information see at event description.Investigation summary: the event unit was not returned for evaluation; however, an image was provided.In the absence of the subject device, it is difficult to determine the root cause of the incident.During the manufacturing assembly process, applied medical graspers are functionally tested 100%.Although the root cause of your experience could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary ensure the performance and safety of our product.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

Event Description

Patient status: patient did not get any injury.Intervention: no intervention.

• Brand Name: C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX
• Type of Device: NWV
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5457867
• MDR Text Key: 38979383
• Report Number: 2027111-2016-00161
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: 00607915110147
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

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 Model Number: C4130
• Device Catalogue Number: 101419801
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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