MAUDE Adverse Event Report: DAKO NORTH AMERICA, INC DAKO OMNIS

Model Number GI100

Device Problems Leak/Splash (1354); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 08/02/2020

Event Type  malfunction  

Event Description

Based on complaint report and investigated failure mode, there was potential for a staining alteration.Customer complaint record reported the event as follows: instrument leaking.No direct or indirect patient harm or user harm has been reported.

• Brand Name: DAKO OMNIS
• Type of Device: DAKO OMNIS
• Manufacturer (Section D): DAKO NORTH AMERICA, INC; 6392 via real; carpinteria, ca, ca
• Manufacturer (Section G): DAKO DENMARK APS; produktionsvej 42; glostrup, 2600 ; DA 2600
• Manufacturer Contact: thiago lima ; produktionsvej 42; glostrup, 2600 ; DA 2600
• MDR Report Key: 10424249
• MDR Text Key: 203999581
• Report Number: 2022180-2020-00239
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GI100
• Device Catalogue Number: GI10030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1