MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY - AMERICA, INC. STORZ; INSUFFLATOR, LAPAROSCOPIC

Model Number 20400161S

Device Problems Crack (1135); Leak/Splash (1354); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 02/18/2021

Event Type  malfunction  

Event Description

At the beginning of the case when staff went to insert the plastic piece inside the tubing that connects to the trocar it kept coming out of the tubing, would not stay in place.Obtained a second package, the plastic piece near the tip was cracked and leaking.Third package worked fine.

• Brand Name: STORZ
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): KARL STORZ ENDOSCOPY - AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 11601949
• MDR Text Key: 243404340
• Report Number: 11601949
• Device Sequence Number: 1
• Product Code: HIF
• 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: 03/19/2021,02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 20400161S
• Device Catalogue Number: 20400161S
• Device Lot Number: 155821
• 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: 03/19/2021
• Date Report to Manufacturer: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15695 DA