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.

• 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
• MDR Report Key: 16397434
• MDR Text Key: 309762150
• Report Number: 2020550-2023-00044
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2023,02/17/2023

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
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other