MAUDE Adverse Event Report: SPIEGELBERG GMBH & CO. KG STIEGLITZ SUCTION AND IRRIGATION DEVICE

Model Number INS01.001.01

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2016

Event Type  malfunction  

Event Description

The push button of four stieglitz suction and irrigation devices stuck during an application.Afterwards, the devices could no longer be used.

Manufacturer Narrative

The device was not returned for evaluation.No patient harm was reported.In the event of a failure of a suction-irrigation device, the defective device is discarded and a new device used.Thus, no patient harm is expected in case of recurrence.

Event Description

The push button of four stieglitz suction and irrigation devices stuck during an application.Afterwards, the devices could no longer be used.

• Brand Name: STIEGLITZ SUCTION AND IRRIGATION DEVICE
• Type of Device: STIEGLITZ SUCTION AND IRRIGATION DEVICE
• Manufacturer (Section D): SPIEGELBERG GMBH & CO. KG; tempowerkring 4; hamburg, 21079 ; GM 21079
• Manufacturer (Section G): SPIEGELBERG GMBH & CO. KG; tempowerkring 4; hamburg, 21079 ; GM 21079
• Manufacturer Contact: leonhard blaurock ; tempowerkring 4; hamburg, 21079 ; GM 21079 ; 0 7901780
• MDR Report Key: 6572160
• MDR Text Key: 75346738
• Report Number: 3002108226-2017-00003
• Device Sequence Number: 1
• Product Code: GZX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INS01.001.01
• Device Catalogue Number: INS01.001.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2016
• 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