MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION EPIX LAPAROSCOPIC GRASPER 5MM X 35; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Catalog Number C4130

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

Event Date 10/26/2023

Event Type  malfunction  

Event Description

Today we had a disposable epix laparoscopic grasper break during use.All parts of the instrument are intact (visible break), and no remnants of the instrument were found or left in the patient.

• Brand Name: EPIX LAPAROSCOPIC GRASPER 5MM X 35
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION
• MDR Report Key: 18064618
• MDR Text Key: 327485931
• Report Number: MW5147682
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/26/2023

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 Catalogue Number: C4130
• Device Lot Number: 1500606
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Female