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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 Problem with Sterilization (1596); Suction Problem (2170); Contamination /Decontamination Problem (2895)
Patient Problem No Code Available (3191)
Event Date 10/26/2018
Event Type  malfunction  
Event Description
The patient was taken to the operating room for revision of the right ossicular chain reconstruction, evaluation of re-current "choleastoma", and left sided removal of retained middle ear tube. The same peds panetti instrument set was used during this procedure, by the same surgeon. The surgeon was unable to establish suction through the instrument. The instrument was removed from the sterile field and flushed by the scrub tech on the back table. After flushing, debris appearing to be biological matter was expelled from the instrument. The sterile field was broken down, and the patient was re-prepped and re-draped. The instrument set was replaced. 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. The instruments were taken out of service to undergo further evaluation of the cleaning/decontamination process and determine patient exposure since the instruments sets were put in use. Manufacturer response for surgical instrument set, panetti endoscopic instrument set (per site reporter).
 
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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 Key8132385
MDR Text Key129306399
Report Number8132385
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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