MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC.; TUBING, INSUFFLATION

Catalog Number 20400161S

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2018

Event Type  malfunction  

Event Description

Upon removing from sterile packaging, the storz high flow insufflation tubing with filter was cracked around the base near filter.

• Type of Device: TUBING, INSUFFLATION
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 7921749
• MDR Text Key: 122175594
• Report Number: 7921749
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 20400161S
• Device Lot Number: 133142
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14965 DA