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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPIGGLE & THEIS MEDIZINTECHNIK GMBH PANETTI SUCTION INSTRUMENTS TUBE, EAR SUCTION

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SPIGGLE & THEIS MEDIZINTECHNIK GMBH PANETTI SUCTION INSTRUMENTS TUBE, EAR SUCTION Back to Search Results
Model Number 30-1860
Device Problems Suction Problem (2170); Contamination /Decontamination Problem (2895)
Patient Problem Exposure to Body Fluids (1745)
Event Date 10/12/2018
Event Type  malfunction  
Event Description
The patient was taken to the operating room for a left tympanomastoidectomy and bilateral adenoidectomy. During the procedure, the surgeon used an instrument from the peds panetti endoscopic otology set (instrument #30-1860) to suction fluid on a drape in the sterile field. The surgeon found that the suction was clogged. The rn flushed the lumen using saline into a bowl and there appeared to be bioburden thought to be clotted blood expelled from the lumen. The instrument did not come into direct contact with the patient; however, the fluid suctioned from the drape was in contact with the surgical incision raising concern for contamination. The bowl and instrument were removed from the sterile field. The patient was not re-prepped and re-draped. The vendor recommended cleaning the instruments using a 3 mach irrigation system and a high pressure water source. We do not own a 3 mach irrigation system, but "was" assured by the vendor that the in-house pure processing flexi-pump would provide adequate volume and pressure to flush the instruments efficiently and to decontaminate the instruments. We have subsequently been told the pure processing flexi-pump does not provide adequate volume and pressure to flush and decontaminate the instruments effectively. The pediatric operating room nursing staff also received in-service training of instrument use. This training did not include specific pre-cleaning instructions that, per the ifu, include using a wire to check inner lumen patency, rinsing instruments with a suitable cleaner or disinfectant, and storing instruments in a suitable cleaner or disinfectant if not processed within one hour after usage. Manufacturer is spiggle & theis. Distributor is (b)(4).
 
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Brand NamePANETTI SUCTION INSTRUMENTS
Type of DeviceTUBE, EAR SUCTION
Manufacturer (Section D)
SPIGGLE & THEIS MEDIZINTECHNIK GMBH
jedmed
5416 jedmed ct
saint louis MO 63129
MDR Report Key8132396
MDR Text Key129306747
Report Number8132396
Device Sequence Number1
Product Code JZF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number30-1860
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/03/2018
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer12/05/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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