MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR INSTRUMENT

Model Number UNKNOWN

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 12/09/2020

Event Type  Injury  

Event Description

It was reported that a patient came back after a neuro procedure for follow-up and an mri or x-ray revealed a piece of a foreign body which appears to be tip of a bipolar instrument.There is no further information on this complaint, and it is not known which product was used in the surgery that took place previously.No further information was provided about the product used other than the device was a bipolar instrument.

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The previous reportability decision for this event was reversed based on a retrospective review.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: BIPOLAR INSTRUMENT
• Type of Device: BIPOLAR INSTRUMENT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17814463
• MDR Text Key: 324210292
• Report Number: 2020550-2023-00269
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/25/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other