MAUDE Adverse Event Report: WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB NAVINA CLASSIC SYSTEM; GASTROINTESTINAL TUBE AND ACCESSORIES

Model Number	69005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Perforation (2668)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has not received the device lot number, or the used product for investigation.Without the benefit of examination and testing the device, or any lot number information, wellspect healthcare is precluded from commenting on the condition of the device or cause of occurrence.Should the device or additional information be received, a follow up report will be filed.
Event or Problem Description
According to the reporter, the patient accidentally lost her balance during insertion of the rectal catheter (provided in the navina classic system).This led to bowel perforation.The patient immediately sought medical care and a permanent fistula was placed.The patient recovered without further sequelae.

• Brand Name: NAVINA CLASSIC SYSTEM
• Common Device Name: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB; aminogatan 1; p.o. box 14; mölndal, sweden SE-43 121; SW SE-43121
• MDR Report Key: 7497585
• Report Number: 3009632672-2018-00003
• Device Sequence Number: 11204733
• Product Code: KNT
• UDI-Device Identifier: 07392532198434
• UDI-Public: 07392532198434
• Combination Product (Y/N): N
• PMA/510(K) Number: K170487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 69005
• Device Catalogue Number: 69005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/09/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 80 YR
• Patient Weight: 59