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

Model Number 27050XA

Device Problem Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

Product has not been returned to karl storz (b)(4) for further review.The date code was not provided by the customer.

Event Description

Per the factory in (b)(4), allegedly there was an event which occurred in (b)(6) that during prostate resection, a breakdown of the distal ceramic part occurred with the release of fragments in the bladder and then recovered in full.

Manufacturer Narrative

Upon evaluation the ceramic tip was found to be broken off.The broken off piece was not returned.Were the ceramic broke off adhesive on the sheath is still visible.No indication for an adherence issue.The remaining fragments are showing different crack paths.Most likely an initial crack was induced by hitting another object.Cracks can grow over time, material stress due to heat change can accelerate the process.The root cause most likely was a high force impact which led to cracks and finally to the breakage of the ceramic tip.Sheaths with ceramic tips must be handled carefully.The sheaths must be checked for cracks or other damages.See ifu p.7.No indication for a systematic issue found during investigation.

• Brand Name: TUBE,INNER,ROTATABLE,CERAMIC
• Type of Device: INNER TUBE
• 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 east grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 9940978
• MDR Text Key: 199987363
• Report Number: 9610617-2020-00045
• 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: Literature,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2020

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 Model Number: 27050XA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 08/09/2022
• 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: Reuse
• Patient Sequence Number: 1