MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MICRO OSTEOTOME EXTRA DELICATE, 4 MM; SURGICAL GOUGE

Model Number 486224

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The item 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 the tip of the micro-osteotome stuck in the patient's body.No information regarding the state of health is available.

Manufacturer Narrative

Based on the customers information, the item in question is not available for further evaluation.According to evaluation results, the item was manufactured in 2004.The most probable root cause can be traced back to an end-of-life issue.The reprocessing instructions refer to the service life of an item.The end of the product's life is largely determined by wear and tear, the reprocessing procedures, the chemicals used, and any damage caused by use.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: MICRO OSTEOTOME EXTRA DELICATE, 4 MM
• Type of Device: SURGICAL GOUGE
• 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: 16397824
• MDR Text Key: 309772343
• Report Number: 9610617-2023-00044
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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: 04/27/2023

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: 486224
• Device Catalogue Number: 486224
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 04/27/2023
• 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
• Patient Outcome(s): Other