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

Model Number C4120

Device Problem Material Frayed (1262)

Patient Problem Bowel Perforation (2668)

Event Date 08/02/2023

Event Type  Injury  

Event 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.

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: 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.

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
• Type of Device: 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
• MDR Text Key: 321586132
• Report Number: 2027111-2023-00569
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)251009(30)01(10)1465118
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• 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
• Patient Outcome(s): Required Intervention