MAUDE Adverse Event Report: KARL STORZ GMBH CO. KG CLICKLINE; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number 33121

Device Problems Material Fragmentation (1261); Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/10/2023

Event Type  malfunction  

Event Description

Karl storz laparoscopic instrument was used in operating room (or) for a total hysterectomy.Black material discovered intra-operatively, and found to be pieces of outer sheath insulation of the working insert.All the fragments were retrieved.

• Brand Name: CLICKLINE
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): KARL STORZ GMBH CO. KG; 2151 e. grand ave; el segundo CA 90245
• MDR Report Key: 16276933
• MDR Text Key: 308539879
• Report Number: 16276933
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 33121
• Device Catalogue Number: 33121 CLICK LINE
• Device Lot Number: 008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17885 DA
• Patient Sex: Female
• Patient Weight: 82 KG