MAUDE Adverse Event Report: KARL STORZ SE & CO. KG KARL STORZ - ENDOSKOPE; LARYNGOSCOPE, NON-RIGID

Catalog Number 091361-01

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Description

Was emailed that the product, storz flexible single use scope was recalled.Ref # (b)(4).To pull all product from use.Fill out the form.Forwarded the recall information to other healthcare professionals at our institution to make them aware, as well as our manager.Fda safety report id# (b)(4).

• Brand Name: KARL STORZ - ENDOSKOPE
• Type of Device: LARYNGOSCOPE, NON-RIGID
• Manufacturer (Section D): KARL STORZ SE & CO. KG; tuttlingen 78532 DE; GM 78532 DE
• MDR Report Key: 12525528
• MDR Text Key: 273540104
• Report Number: MW5104175
• Device Sequence Number: 1
• Product Code: CAL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/21/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2022
• Device Catalogue Number: 091361-01
• Device Lot Number: 500335
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1