MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH FOR 27050 SC

Model Number 27050CA

Device Problem No Apparent Adverse Event (3189)

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

Event Date 02/01/2021

Event Type  malfunction  

Event Description

It was reported that part of the device broke off during surgical procedure.Surgeon retrieved the broken part, no harm to the patient.

Manufacturer Narrative

The previous reportability decision for this event was reversed based on a retrospective review.The affected device has been requested for investigation by the manufacturer.Device was returned for investigation.Investigation findings: broken ceramic beak and scratched, distal end is dented with burrs where the beak once was.The shaft is severely scratched.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INNER SHEATH FOR 27050 SC
• Type of Device: INNER SHEATH FOR 27050 SC
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: christiane klaiber ; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17970225
• MDR Text Key: 326455605
• Report Number: 9610617-2023-00301
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551077412
• UDI-Public: 4048551077412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/19/2023

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: 27050CA
• Device Catalogue Number: 27050CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1