MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TUBE,INNER,CERAMIC INSULATION

Model Number 27040XA

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The event occurred in new zealand.As stated by the customer: we have a customer that discovered a ceramic end from 27040xa inner sheath that had been left in a patient from a previous surgery 4 years ago.It has since been removed but our customer is asking if this is a known issue with the ceramic end of the inner sheath? it was confirmed that the information was not forwarded 4 years ago.Since the potential risk in case of reoccurrence is higher than remote, a report is required.Additionally, a report to the authority of new zealand is required.The item in question was not returned.According to the customer description, this process is a user error.On the one hand, the reason is improper handling (see note ifu) and the item must be checked for damage before each use.Since the age of the socket is not known, the material may have caused material fatigue due to high age and the resulting number of reprocessing (refer to the instructions for use, 97000126; version: 3.0_03/2019) the event is filed under internal karl storz complaint id: (b)(4).

Event Description

The customer discovered a ceramic end from 27040xa inner sheath that had been left in a patient from a previous surgery 4 years ago.It has since been removed but our customer.Additional patient information is not available.

• Brand Name: TUBE,INNER,CERAMIC INSULATION
• Type of Device: TUBE,INNER,CERAMIC INSULATION
• 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: anja fair ; 2151 e grand ave; el segundo, CA ; 4242188738
• MDR Report Key: 16584869
• MDR Text Key: 311740531
• Report Number: 9610617-2023-00063
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 4048551076521
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27040XA
• Device Catalogue Number: 27040XA
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other