MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4120, 38CM GRASPER REPOS CART, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4120
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	08/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: laparascopic right hemicolectomy.Event description: the small bowel was being grasped during hemicolectomy when the event occurred.Message from cns: [name] performing lap right hemi; "yesterday we had a faulty grasper (c4120 ¿ lot:1465118).It had a piece of the mesh material sticking out and it made a small hole in the small bowel.The grasper wasn¿t checked prior to use but was noticed as the surgeon grabbed the bowel with the grasper and a hole formed." the small bowel was punctured.It was subsequently repaired.Device replaced with another c4120.Additional information received from [name] via email on (b)(6) 2023.Small bowel was repaired by suturing.Bleeding and small bowel damage.Intervention: small bowel was repaired by suturing.Device replaced with another c4120.Patient status: small bowel was repaired and patient is stable.
Additional 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 or Problem Description
Procedure performed: laparascopic right hemicolectomy.Event description: the small bowel was being grasped during hemicolectomy when the event occurred.Message from cns: [name] performing lap right hemi; "yesterday we had a faulty grasper (c4120 ¿ lot:1465118).It had a piece of the mesh material sticking out and it made a small hole in the small bowel.The grasper wasn¿t checked prior to use but was noticed as the surgeon grabbed the bowel with the grasper and a hole formed.".The small bowel was punctured.It was subsequently repaired.Device replaced with another c4120.Additional information received from [name] via email on 14-aug-2023.Small bowel was repaired by suturing.Bleeding and small bowel damage.Intervention: small bowel was repaired by suturing.Device replaced with another c4120.Patient status: small bowel was repaired and patient is stable.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed a frayed latis pad.Testing was performed on the returned unit; however, the complainant¿s experience of tissue trauma could not be replicated as the latis pads did not snag or puncture tissue during functional testing.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event 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.

• Brand Name: C4120, 38CM GRASPER REPOS CART, 10/BX
• Common Device Name: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17588611
• Report Number: 2027111-2023-00569
• Device Sequence Number: 6467147
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)251009(30)01(10)1465118
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2025
• Device Model Number: C4120
• Device Catalogue Number: 101472471
• Device Lot Number: 1465118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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: Required Intervention
• Patient Sex: Unknown