MAUDE Adverse Event Report: KARL STORZ SE & CO. KG. BERCI FASCIAL CLOSURE DEVICE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 26173AM

Device Problems Break (1069); Device Fell (4014)

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

Event Date 08/25/2022

Event Type  malfunction  

Event Description

Tip broke off storz berci fascial closure device and fell into the pt's abdomen.Fortunately the piece was retrieved using laparoscopic graspers and there was no harm to the patient.Fda safety report id # (b)(4).

• Brand Name: BERCI FASCIAL CLOSURE DEVICE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): KARL STORZ SE & CO. KG.
• MDR Report Key: 15607077
• MDR Text Key: 301947913
• Report Number: MW5112655
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 10/12/2022

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: 26173AM
• Device Lot Number: XU03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male