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

Model Number	C4121
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Bowel Perforation (2668)
Date of Event	09/06/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Robotic left sigmoid colectomy - "a robotic left sigmoid colectomy was performed on (b)(6).On (b)(6) the patient was brought back to surgery for a small bowel leak repair.Concern was that the small bowel was damaged while being retracted via the reposable graspers during the (b)(6) surgery that led to the patient needing a second surgery on (b)(6)." additional information received via email/phone from applied medical team members - case was completed and 2-3 days after the patient came back to the hospital.Found that there tears/holes in the patient's bowel.Or team determined that graspers were used in this case and concluded that the tears / holes can be attributed to the graspers used.It was confirmed that the surgeon was manipulating the tissue and using the device in both cases type of intervention- patient needed a second surgery.
Additional Manufacturer Narrative
The event product was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.A review of the manufacturing records showed that this lot passed all manufacturing and quality standards.All graspers undergo 100% visual and functional inspection during the manufacturing and assembly process.The root cause of the event could not be confirmed; however, it is possible that user exerted high amounts of force when using the grasper.It is important to note the potential complications associated with the use of graspers, as stated in the instructions for use (ifu), include, but are not limited to: local trauma, injury, and tissue necrosis.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• Brand Name: C4121, 45CM GRASPER REPOS CART, 10/BX
• Common Device Name: NWV
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6031831
• Report Number: 2027111-2016-00688
• Device Sequence Number: 16230298
• Product Code: NWV
• UDI-Device Identifier: 00607915116873
• UDI-Public: (01)00607915116873(17)190421(30)01(10)1269735
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2016

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2016
• Supplement Report FDA Received Date: 12/09/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention