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

Model Number C4121

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

Patient Problems Injury (2348); Bowel Perforation (2668)

Event Date 09/06/2016

Event Type  Injury  

Manufacturer Narrative

Additional information requested and received.No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.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

Robotic assisted left sigmoid colectomy- "during a (b)(6) robotic asst.Left sigmoid colectomy, the dr.Noticed two holes in the small bowel that needed to be repaired and a sew over enterotomy was performed.The dr noticed the holes in the small bowel was consistent with the size and shape of the latis pads on the direct drive graspers." additional information received via email/phone from applied medical team members on september 22, 2016 - while doctor was grasping tissue, found two small holes that were a similar size to the latis mesh pads.Or team determined that graspers caused the tears/holes.Enterotomy was performed as intervention.It was confirmed that the surgeon was manipulating the tissue and using the device in both cases.Type of intervention- "enterotomy performed and procedure continued." patient status: 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.

• 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: 6031067
• MDR Text Key: 57486061
• Report Number: 2027111-2016-00687
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915116873
• UDI-Public: (01)00607915116873(17)190421(30)01(10)1269735
• 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?: Yes
• Device Operator: Other
• Device Expiration Date: 04/21/2019
• Device Model Number: C4121
• Device Catalogue Number: 100864101
• Device Lot Number: 1269735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention