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

Model Number C4130

Device Problem Flaked (1246)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 282578452
• Report Number: 2027111-2021-00710
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)240315(30)01(10)1411720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5MM ENDOPATH EXCEL TROCAR