MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4130
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Name of procedure being performed: unsure detailed description of event: as per attached form filled out by nurse attending, part of the device came off in patient.Quality report form from hospital states that small piece detached from grasper tip.Patient status: no adverse event for patient.Type of intervention: surgeon had to locate the lost piece from abdomen - no complications.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, photographs of the event unit and the detached piece were provided, confirming the complainant¿s experience of pad detachment.Based on similar events, it is likely that the reported event was caused by adhesive failure.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
Name of procedure being performed: unsure.Detailed description of event: as per attached form filled out by nurse attending, part of the device came off in patient.Quality report form from hospital states that small piece detached from grasper tip.Patient status: no adverse event for patient.Type of intervention: surgeon had to locate the lost piece from abdomen - no complications.

• Brand Name: C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX
• Common Device Name: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 12929608
• Report Number: 2027111-2021-00754
• Device Sequence Number: 12186602
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)240520(30)01(10)1417785
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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: 05/20/2024
• Device Model Number: C4130
• Device Catalogue Number: 101419801
• Device Lot Number: 1417785
• 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: 11/12/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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