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

Model Number 27050XA

Device Problem Material Fragmentation (1261)

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

Event Date 08/03/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer incident report #(b)(4) received from the factory in germany.The affected device has been requested for investigation by the manufacturer.

Event Description

The reported event happened in austria.According to information received, during a case, the ceramic tip broke off inside the patient.The fragment could be retrieved.The case could be completed with another instrument.This caused a surgery extension.No injury to a patient, the user, or a third was reported.A complaint review for this article and similar articles was performed for the timeframe 03-aug-2020 - 02-sep-2022.Adverse events that could be considered as similar to the current one and caused or contributed to serious injury could be found.Thus, it is concluded that contribution to a serious injury of this malfunction is likely and a report to the fda is required.

Manufacturer Narrative

The article complaint about was repaired by a third-party.This is indicated by the foreign batch number on the shaft, which does not belong to karl storz.Therefore, it can be concluded that the article 27050xa was not repaired at karl storz, and therefore no longer meets the karl storz quality standard.Additional the most probable root cause for the cracks and spalling is the reprocessing process.As the user did not consider that the wall thickness decreases and becomes thinner until it is so thin that cracks and spalling can occur.

Event Description

Internal reference number: (b)(4).

• Brand Name: TUBE,INNER,ROTATABLE,CERAMIC
• Type of Device: ,ROTATABLE INNER TUBE
• 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 90245-5017 ; 4242188738
• MDR Report Key: 15366006
• MDR Text Key: 299358640
• Report Number: 9610617-2022-00262
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551078136
• UDI-Public: 4048551078136
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27050XA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other