MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4120, 38CM GRASPER REPOS CART, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4120
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
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 of rough actuation was caused by the rivet being too tight which occurred during the manufacturing process.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This report is a combined initial/final report.
Event or Problem Description
Procedure performed: not known.Extremely limited information available.Surgeon uses this product routinely and does not have issues with it.On this occasion surgeon commenced using grasper and stated the jaws were "too tight" (difficult to open) and ceased using.No information available as to when jaws became tight or if they were tight from the beginning of use.Reposable shaft was replaced with a new one and case proceeded as usual.The reuseable handle remained the same.Patient was not affected.No information on other instruments used at the time or what procedure.Patient status: patient did not incur injury.Type of intervention: product replacement during case.

• Brand Name: C4120, 38CM GRASPER REPOS CART, 10/BX
• Common Device Name: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8761164
• Report Number: 2027111-2019-00503
• Device Sequence Number: 11272519
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)211003(30)01(10)1137601
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 07/03/2019

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 Expiration Date: 10/03/2021
• Device Model Number: C4120
• Device Catalogue Number: 101472471
• Device Lot Number: 1337601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 07/03/2019
• Patient Sequence Number: 1