MAUDE Adverse Event Report: AESCULAP, INC. AESCULAP PRESTIGE GRASPER; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number 8360-00

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

Event Date 07/28/2023

Event Type  Injury  

Event Description

During laparoscopic ovarian cystectomy, dr.(b)(6) inserted an asculap prestige grasper(part # 8360-00) into a trocar.Once she opened the grasper, it remained in an open position, she had difficulty closing and removing the grasper from the patient.Upon removal scrub technician noted the jaw of the grasper separated from the main body, and suspected a pin was missing.Drs.(b)(6) inspected the sterile field while scrub technician searched for suspected item on back table.I searched the floor and surrounding area.No suspected pin noted.Radiology was called while surgery continued.Additional scrub technician entered the room, their search revealed a metal fragment on the floor.Radiology performed an xray, no foreign body was noted.

• Brand Name: AESCULAP PRESTIGE GRASPER
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): AESCULAP, INC.
• MDR Report Key: 17624240
• MDR Text Key: 322101758
• Report Number: MW5144954
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/21/2023

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: 8360-00
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 72 KG