MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4119, 32CM GRASPER REPOS CART, 10/BX; NWV

Model Number	1
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2017
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.
Event or Problem Description
Procedure performed: unknown.Incident description: (b)(4) incident reported by email by clinical procurement.Details of the complaint listed as "the blue pad from the tip of the grasper came off".Patient status: unknown.Type of intervention: unknown.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Visual inspection confirmed the complainant's experience of pad detachment.Based on the condition of the returned unit, it is likely that the reported event was caused during manufacturing, either from a lack of adhesive or from repositioning or readjusting the pad during curing.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: C4119, 32CM 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: 6793276
• Report Number: 2027111-2017-01935
• Device Sequence Number: 11148080
• Product Code: NWV
• UDI-Device Identifier: 00607915116859
• UDI-Public: (01)00607915116859(17)191214(30)01(10)1285427
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: 1
• 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
• Report Date (Section B): 10/06/2017

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: 12/14/2019
• Device Model Number: 1
• Device Catalogue Number: 1
• Device Lot Number: 1285427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 10/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1