MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER CERAMIC TUBE; 26FR. FIXED INNER TUBE

Model Number 27040XA

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

The manufactures internal number is (b)(4).Investigaton is on-going.Initial exam of the product finds the ceramic tip was broken on the distal tip.There are dents on the shaft, with further inspection there is rust build up in the luber.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.Ifu for ceramic beaks pi-000005 v6.0 (09-2020) states do not use a sheath with any signs of damage to the ceramic insulation as it may fail in use and cause injuries to the patient.Deflecting obturators must be properly locked into the sheath prior to use.

Event Description

It was reported that there was an issue with the product 27040xa ceramic inner tube.According to the information received the ceramic beak broke off in the patient.All parts were recovered and confirmed with surgeon.There was no patient harm/injury reported.Additional information has been requested but not yet received as of the date of this report.

Manufacturer Narrative

Per the manufactures findings: based on the damage seen, the breakage of the ceramic beak may have been caused by pulling the inner shaft out of the outer shaft at an angle.When the inner shaft is pulled out of the outer shaft at an angle this presses the ceramic against the outer shaft and can cause it to break.In addition, the ifu points out that the ceramic beak should be checked for damage before use.The manufactures internal number is (b)(4).

• Brand Name: INNER CERAMIC TUBE
• Type of Device: 26FR. FIXED INNER TUBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 17556843
• MDR Text Key: 321436843
• Report Number: 9610617-2023-00204
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 4048551076521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

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: 27040XA
• Device Catalogue Number: 27040XA
• Device Lot Number: NR03
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• 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