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

Model Number C4120

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); Bowel Perforation (2668)

Event Date 08/04/2016

Event Type  Injury  

Manufacturer Narrative

Additional information was requested from the customer and provided.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 exploratory small bowel obstruction - "either c4119 or c4120 unknown lot.Dr.Was running the bowel, the grasped made an indentation and made a small tear in the bowl and the doctor had to convert to open surgery.The part of the bowel that was being removed is the section that involved the tear." additional information received: the doctor said that the tear in the tissue was not caused by diseased tissue, but believes that there has been a change in the mesh pads not having as much padding.Patient status- no patient injury.

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.

Event Description

Additional information received via email from tma on august 26, 2016: "there was only one case where tissue tore.".

• 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
• Manufacturer Contact: jennifer scoullar ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138000
• MDR Report Key: 5932579
• MDR Text Key: 54061587
• Report Number: 2027111-2016-00613
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: 00607915116866
• 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: 05/09/2017

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?: No
• Device Operator: Other
• Device Model Number: C4120
• Device Catalogue Number: 100864001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2016
• Initial Date FDA Received: 09/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention