MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES DIRECT DRIVE REPOSABLE GRASPERS; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.The probability and criticality of the harm resulting from this event have been evaluated and were found to be at an acceptable level.This report is a follow-up to mw5160650.
Event or Problem Description
Complaint created from medwatch, mdr report # mw5160650.This is an anonymous complaint filed by an unknown reporter via medwatch.Thus, no further information can be obtained.During surgery, the grasper tip was coming off of the instrument and noticed.Removed from patient and determined all was still intact and out of the patient during removal and after removal.Instrument removed from the sterile field.Intervention: removed fallen grasper tip from patient.Patient status: ni.
Event or Problem Description
Procedure performed: ni.Event description: complaint created from medwatch, mdr report # mw5160650.This is an anonymous complaint filed by an unknown reporter via medwatch.Thus, no further information can be obtained.During surgery, the grasper tip was coming off of the instrument and noticed.Removed from patient and determined all was still intact and out of the patient during removal and after removal.Instrument removed from the sterile field.Intervention: removed fallen grasper tip from patient.Patient status: ni.
Additional Manufacturer Narrative
The event unit is not being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.This report is a follow-up to mw5160650.

• Brand Name: DIRECT DRIVE REPOSABLE GRASPERS
• Common Device Name: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 20763695
• Report Number: 2027111-2024-00924
• Device Sequence Number: 9446540
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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: C4120
• Device Catalogue Number: 101476259
• Device Lot Number: 1519143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 130 KG
• Patient Ethnicity: Hispanic
• Patient Race: White