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

Model Number	C4130
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
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
Procedure performed: appendectomy event description: complaint created based off of medwatch uf/importer report # (b)(4).[hospital] "upon using epix laparoscopic grasper (ref# c4130, lot #1 512170), a thread on the pad, at the tip of the grasper became caught upon the intestines when using the grasper, during removal of the appendix.Irritation and redness seen where the thread was, upon usage of the grasper.Surgeon assessed the area of the intestines and determined that there was no active bleeding and processed with appendectomy." additional information received from [customer] via email on 30jul2024: [hospital] does purchase devices directly from amr.The department no longer has the device, device was discharged.The product is not available for return.Additional information received from [customer] via email on 30jul2024: the graspers that the hospital purchases do not come as part of a kit.The hospital purchases applied medical graspers by the box, qty (b)(4).Additional information received from [customer] via email on 1aug2024: the complaint occurred at [hospital] which is under [hospital]'s license.[hospital] is [hospital]'s campus in [location].Intervention: surgeon assessed the area of the intestines and determined that there was no active bleeding and processed with appendectomy.Patient status: no patient injury.
Event or Problem Description
Procedure performed: appendectomy.Event description: complaint created based off of medwatch uf/importer report (b)(4) [hospital]."upon using epix laparoscopic grasper (ref#c4130, lot #1512170), a thread on the pad, at the tip of the grasper became caught upon the intestines when using the grasper, during removal of the appendix.Irritation and redness seen where the thread was, upon usage of the grasper.Surgeon assessed the area of the intestines and determined that there was no active bleeding and processed with appendectomy." additional information received from [customer] via email on 30jul2024: [hospital] does purchase devices directly from amr.The department no longer has the device, device was discharged.The product is not available for return.Additional information received from [customer] via email on 30jul2024: the graspers that the hospital purchases do not come as part of a kit.The hospital purchases applied medical graspers by the box, qty 10.Additional information received from [customer] via email on 1aug2024: the complaint occurred at [hospital] which is under [hospital]'s license.[hospital] is [hospital]'s campus in [location].Intervention: surgeon assessed the area of the intestines and determined that there was no active bleeding and processed with appendectomy.Patient status: no patient injury.
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.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical has performed a historical trend analysis and review of production records and no trends identified.The probability and criticality of the harm resulting from this event have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: appendectomy.Event description: complaint created based off of medwatch uf/importer report#: (b)(4).[hospital]: "upon using epix laparoscopic grasper (ref#: c4130, lot#: 1512170), a thread on the pad, at the tip of the grasper became caught upon the intestines when using the grasper, during removal of the appendix.Irritation and redness seen where the thread was, upon usage of the grasper.Surgeon assessed the area of the intestines and determined that there was no active bleeding and processed with appendectomy." additional information received from [customer] via email on 30jul2024: [hospital] does purchase devices directly from amr.The department no longer has the device, device was discharged.The product is not available for return.Additional information received from [customer] via email on 30jul2024: the graspers that the hospital purchases do not come as part of a kit.The hospital purchases applied medical graspers by the box, qty (b)(4).Additional information received from [customer] via email on 1aug2024: the complaint occurred at [hospital] which is under [hospital]'s license.[hospital] is [hospital]'s campus in [location].Intervention: surgeon assessed the area of the intestines and determined that there was no active bleeding and processed with appendectomy.Patient status: no patient injury.
Additional Manufacturer Narrative
This report is being updated and submitted per the fda request.Correction: section b1 is being updated to "adverse event." h1 is being updated to ¿serious injury.".

• 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: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 20019033
• Report Number: 2027111-2024-00789
• Device Sequence Number: 12624668
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)270110(30)01(10)1512170
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C4130
• Device Catalogue Number: 101476261
• Device Lot Number: 1512170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 11/14/2024; 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Sex: Unknown