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

Model Number C4130

Device Problems Entrapment of Device (1212); Material Frayed (1262); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

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

Event Date 01/22/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Procedure performed: appendectomy.Event description: today (on (b)(6) 2023) i got another cer from the same hospital.The jaws of the grasping forceps stuck to the tissue several times during the procedure.One suspects an uncleanly manufactured jaws.Additional information received from applied medical representative confirmed in person on (b)(6) 2023: the customer is returning the device.Incidents (b)(4) are identical in terms of how the jaws were stuck to the tissue.Stitched over the tissue for security.The tissue came loose after several attempts to pull on it.Intervention: stitched over the tissue for security.The tissue came loose after several attempts to pull on it.Patient status: no patient harm has been reported.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Functional testing confirmed the complainant¿s experience of tissue sticking.Visual inspection confirmed that the latis of the grasper pad was frayed.Based on the condition of the returned unit, the reported event likely occurred as a result of the use of the grasper.However, applied medical is unable to determine the exact root cause of the pad fraying based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Correction: section h6 (device code) is being updated to reflect the event more accurately based on additional information received from the complainant and results of the investigation.

Event Description

Procedure performed: appendectomy event description: today (25jan23) i got another cer from the same hospital.The jaws of the grasping forceps stuck to the tissue several times during the procedure.Additional information received from applied medical representative confirmed in person on (b)(6) 2023: the customer is returning the device.Stitched over the tissue for security.The tissue came loose after several attempts to pull on it.Intervention: stitched over the tissue for security.The tissue came loose after several attempts to pull on it.Patient status: no patient harm has been reported.

• 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: 16387990
• MDR Text Key: 309759666
• Report Number: 2027111-2023-00345
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)251002(30)01(10)1465120
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

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 Model Number: C4130
• Device Catalogue Number: 101419801
• Device Lot Number: 1465120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2022
• 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: REUSABLE OVERHOLD.