MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG TROCAR

Model Number UNKNOWN

Device Problems Temperature Problem (3022); Device Handling Problem (3265)

Patient Problem Burn(s) (1757)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient received heat burns on their cheek.The twist drill was being used at 30,000 rpm with a trocar.It is stated in ifu 90-274-92-40 and 91-600-00-41 under precautions "when using twist drills, copious amounts of irrigation are mandatory to alleviate excessive heat generation, which can lead to bone necrosis, and in extreme cases, soft tissue burns through contact with trocar and cannula." and "twist drills are not designed to be used at speeds in excess of 5000 rpm.".

Manufacturer Narrative

Device material number nor lot number was identified therefore complaint rate, review of device history records and risk file was not possible.The root cause for the failure cannot be determined since neither material number nor lot number were provided, and the device was not returned.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted. .

• Brand Name: TROCAR
• Type of Device: TROCAR
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 8332127
• MDR Text Key: 135917628
• Report Number: 9610905-2019-00038
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLS 1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model 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?: Yes
• Distributor Facility Aware Date: 05/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2019
• Date Manufacturer Received: 05/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR