MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SHAVER BLADE GYN

Model Number 26208SB

Device Problems Break (1069); Fracture (1260); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

The items in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that two new blades broke as soon as drillcut was started.In this case, it would have been possible for a piece of the blade to have ended up inside the patient.Fortunately, this did not happen when the blade was outside the patient when the piece came off.

Manufacturer Narrative

In the case of the claimed article 26208sb with the lot om02 it was found during inspection that the inner shaft is deformed/bent at the distal end with a crack on the side of the shaft at the transition to the jaw part.In addition, the shaft is bent at the back.It is concluded that it was most probably bent at the back due to excessive force, which led to the concentricity not being given, which spread to the distal end and led to deformation.In the instructions for use of the article it is stated to check the product for functionality, damage and changes to the surface and to not overload the product with mechanical stress.Based on the damages found on the article, it is assumed that this is a case of non-compliance with the ifu/processing instructions.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: SHAVER BLADE GYN
• Type of Device: SHAVER BLADE
• 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
• MDR Report Key: 18519522
• MDR Text Key: 332941557
• Report Number: 9610617-2024-00009
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551274736
• UDI-Public: 4048551274736
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K223520
• 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: 04/26/2024

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: 26208SB
• Device Catalogue Number: 26208SB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: ARTICLE: 26702050 SERIAL: (B)(6)