MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH WITH CERAMIC BEAK; INNER TUBE WITH CERAMIC BEAK

Model Number 27050XA

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

Only the ceramic tip was sent in for investigation.According to the manufacture upon examination they found that the broken surface is partial discolored.Damages like this happen if the ceramic insert is hit against hard objects or edges.The damage of the product is not caused by a production problem or material defect.The ceramic tip is light grey-white, and suggest that it is an old model.Since (b)(6) 2005 dark grey ones were used.

Event Description

As per a vigilance report filed by the factory in germany, allegedly, during a urology procedure in gb, a piece of the ceramic tip broke inside the patient and was undetected at the time.The patient returned 3 months later, the beak was found and removed.

• Brand Name: INNER SHEATH WITH CERAMIC BEAK
• Type of Device: INNER TUBE WITH CERAMIC BEAK
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm,
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188201
• MDR Report Key: 9311529
• MDR Text Key: 194175092
• Report Number: 9610617-2019-00104
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551078136
• UDI-Public: 4048551078136
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2019

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: 27050XA
• Device Catalogue Number: 27050XA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 68