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

Model Number	C4120
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: ni.Additional information received via email from [name] 27.08.2020: i still don¿t have a detailed description, but was told briefly that the jaws couldn't close after opening inside the patient, so the grasper couldn¿t be removed via the port, so had to remove both grasper and port together.When i hear back i can add further comment.Intervention: ni.Patient status: patient is fine, and completely unaffected.
Event or Problem Description
Procedure performed: ni.Additional information received via email from [name] 27.08.2020: i still don¿t have a detailed description, but was told briefly that the jaws couldn¿t close after opening inside the patient, so the grasper couldn¿t be removed via the port, so had to remove both grasper and port together.When i hear back i can add further comment.Intervention: ni.Patient status: patient is fine, and completely unaffected.
Additional Manufacturer Narrative
The event unit along with one 5mm trocar was returned to applied medical for evaluation.Visual inspection of the event unit confirmed that the jaws were unable to be closed and removed from the trocar.Engineering also observed that the formed end of the rivet had partially dislodged from the jaws.Based on the condition of the returned unit, the reported event was caused by the formed end of the rivet that came out of place while the device was being used.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: C4120, 38CM LATIS GRASPER 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: 10731132
• Report Number: 2027111-2020-00597
• Device Sequence Number: 13921336
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)230409(30)01(10)1386204
• 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,Followup
• Report Date (Section B): 11/19/2020

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: 04/09/2023
• Device Model Number: C4120
• Device Catalogue Number: 101473343
• Device Lot Number: 1386204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1