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

Model Number	C4121
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of the investigation.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.There is no report of serious injury or death associated with this event.
Event or Problem Description
"surgeon using grasper to measure bowel, grasper scissored - replacement requested.Concern about this due to previous event with another surgeon's patient and outcome.Please contact dr.(b)(6) for more specific details." patient status - "fine".
Additional Manufacturer Narrative
Name of procedure performed - omega loop.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon visual inspection, engineering found no non-conformances.Functional testing was performed on simulated tissue, resulting in jaw scissoring only when a large amount of force was applied and the unit was torqued while engaged.The likely root cause of the event may have been the operator applying excessive force while manipulating the tissue as engineering was only able to replicate the customer's experience by applying a large amount of force and twisting the unit.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.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.

• Brand Name: C4121, 45CM GRASPER REPOS CART, 10/BX
• Common Device Name: NWV
• Manufacturer (Section D): AMR; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5749442
• Report Number: 2027111-2016-00468
• Device Sequence Number: 13453196
• Product Code: NWV
• UDI-Device Identifier: 00607915116873
• UDI-Public: (01)00607915116873(17)181210(30)01(10)1261075
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2016

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
• Operator of Device: Other
• Device Expiration Date: 12/10/2018
• Device Model Number: C4121
• Device Catalogue Number: 100864101
• Device Lot Number: 1261075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/26/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/25/2016
• Supplement Report FDA Received Date: 12/30/2016; 12/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1