MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C5223, REUSABLE GRASPER HANDLE; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C5223
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed the reported event of rough actuation.Based on the condition of the returned unit, it is likely that the reported event was caused by a deformed component, which caused interference between components within the handle assembly.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Connected the reposable grasper shaft to the grasper handle and the jaws wouldn't open and close correctly.Disposable jaws would not engage correctly.Took it apart and connected it to another handle and worked just fine.Returning just the handle.Patient status: patient not involved.

• Brand Name: C5223, REUSABLE GRASPER HANDLE
• Common Device Name: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8756222
• Report Number: 2027111-2019-00500
• Device Sequence Number: 13952891
• Product Code: NWV
• UDI-Device Identifier: 00607915116972
• UDI-Public: (01)00607915116972(17)330606(30)01(10)1324412
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 07/02/2019

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: Health Professional
• Device Model Number: C5223
• Device Catalogue Number: 100831801
• Device Lot Number: 1324412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1