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

Model Number 836-10 AES 01/18

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

At the end of the case, it was noticed that the laparoscopic double action bowel grasper insulation was flayed open.A thorough exploration and irrigation of the abdominal cavity was performed by the surgeon.

• Brand Name: AESCULAP PRESTIGE LAPAROSCOPIC GRASPER
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): AESCULAP INC.; center valley PA 18034
• MDR Report Key: 19051334
• MDR Text Key: 339628915
• Report Number: MW5153566
• 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: 04/02/2024

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: 836-10 AES 01/18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Hispanic
• Patient Race: White