MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4121, 45CM GRASPER REPOS CART, 10/BX; NWV

Model Number C4121

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Tissue Damage (2104)

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided.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

Omega loop / gastric bypass - "cer created because rep mentioned" doctor "has experienced more than 5 instances where the grasper has caused a bowel injury when performing a gastric bypass." intervention - "unk".Patient status - "unk".

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.Although the exact root cause of the event could not be determined, applied medical has opened a corrective and preventative action report to further elevate and track this investigation and implement appropriate corrective actions, where applicable, to mitigate this type of event.

• Brand Name: C4121, 45CM GRASPER REPOS CART, 10/BX
• Type of Device: NWV
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: jennifer scoullar ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138000
• MDR Report Key: 6111651
• MDR Text Key: 60304510
• Report Number: 2027111-2016-00789
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: C4121
• Device Catalogue Number: 100864101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention