MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EPIX LAPAROSCOPIC GRASPER; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4140
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: gastric sleeve detailed description of event: nurse went to open and noticed a hair inside the packaging nil clinical impact additional information received from applied's senior territory manager via email on may 27, 2025: hospital cannot give us a date.Only that it was found yesterday.Type of intervention: they grabbed a new device and opened it to complete the case patient status: no patient involvement (before use).
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.Based on the description of the event, it is possible that the hairlike object originated from the manufacturing process.However, the exact root cause of the event is unknown.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.
Event or Problem Description
Name of procedure being performed: gastric sleeve.Detailed description of event: nurse went to open and noticed a hair inside the packaging.Nil clinical impact.Additional information received from applied's senior territory manager via email on may 27, 2025: hospital cannot give us a date.Only that it was found yesterday.Type of intervention: they grabbed a new device and opened it to complete the case.Patient status: no impact - before use.

• Brand Name: EPIX LAPAROSCOPIC GRASPER
• 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: 22197881
• Report Number: 2027111-2025-00581
• Device Sequence Number: 9311631
• Product Code: NWV
• UDI-Device Identifier: 00607915110154
• UDI-Public: (01)00607915110154
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: C4140
• Device Catalogue Number: 101476262
• Device Lot Number: 1540574
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2024
• 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 Sex: Unknown