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

Model Number	C4130
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit returned 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: lap chole detailed description of event: i was asked by a surgeon to contact you about one of your products.We were using the "epix laparoscopic grasper" ref# (b)(4) today for a lap chole.The surgeon stated that the green shaft of the instrument was flaking material off into the patient.Small hair like green fibers or paint or something was flaking or coming off of the shaft of the instrument and was ending up inside of her patient." product is available for return.Additional information received via email on 11oct2021 from [name], [facility] service coordinator: the strands were removed from the patient.The following information is from the surgeon of the case.The patient was a thin, young girl going in for an elective case.[.] i have used their instruments a lot before and there was no torque, excess force etc with her case.Additional information received via email on 11oct2021 from [name], [facility] service coordinator: photo of the device has been provided.Additional information received via email on 22oct2021 from (b)(6).(entered by (b)(4)) there is no patient injury at this time.Additional information received via email on 02nov2021 from [name], [facility] service coordinator: the trocar used was a 5mm endopath excel trocar.Additional information received via email on 04nov2021 from [name], [facility] service coordinator: there was another endopath 5mm port.There were other devices used in the procedure, but no other ones that came into contact with that grasper.Patient status: no patient injury type of intervention: the strands were removed from the patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with green particulate.Visual inspection confirmed the complainant's experience of green particulates.The particulates were observed to be from the shaft of the event unit.Based on the condition of the returned unit, the particulates were from scratches along the shaft.However, the exact root cause of the scratches could not be determined.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: lap chole.Detailed description of event: i was asked by a surgeon to contact you about one of your products.We were using the "epix laparoscopic grasper" ref# (b)(4) today for a lap chole.The surgeon stated that the green shaft of the instrument was flaking material off into the patient.Small hair like green fibers or paint or something was flaking or coming off of the shaft of the instrument and was ending up inside of her patient." product is available for return.Additional information received via email on (b)(6) 2021 from [name], [facility] service coordinator: the strands were removed from the patient.The following information is from the surgeon of the case.The patient was a thin, young girl going in for an elective case.[.] i have used their instruments a lot before and there was no torque, excess force etc with her case.Additional information received via email on (b)(6) 2021 from [name], [facility] service coordinator: photo of the device has been provided.Additional information received via email on (b)(6) 2021 from [name], [facility] service coordinator.There is no patient injury at this time.Additional information received via email on (b)(6) 2021 from [name], [facility] service coordinator: the trocar used was a 5mm endopath excel trocar.Additional information received via email on (b)(6) 2021 from [name], [facility] service coordinator: there was another endopath 5mm port.There were other devices used in the procedure, but no other ones that came into contact with that grasper.Patient status: no patient injury.Type of intervention: the strands were removed from the patient.

• 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: 12763640
• Report Number: 2027111-2021-00710
• Device Sequence Number: 4595877
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)240315(30)01(10)1411720
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Health Professional,User Facility
• 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: 03/15/2024
• Device Model Number: C4130
• Device Catalogue Number: 101419801
• Device Lot Number: 1411720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• 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: 10/07/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5MM ENDOPATH EXCEL TROCAR
• Patient Sex: Unknown