MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLEXXUS ENDOSCOPIC BILIARY STENT

Model Number	LXB08100
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alleged label has been provided to the manufacturer for review.As the lot number for the device was not provided, a review of the device history records has not been performed.The device is not available for return.The investigation is currently underway.
Event or Problem Description
It was reported that the unit of gradient magnetic field on the packaging insert was allegedly incorrect.There was no reported patient contact.
Additional Manufacturer Narrative
Manufacturing review: since the reported event is not a lot-specific problem, a specific lot number is not required.Investigation summary: based on the review of the relevant section of the ifu it is confirmed that the inadequate scale unit tesla/second is used to specify the gradient magnetic field.The root cause, for the use of an inadequate scale unit in the instructions for use, could not be determined during the complaint investigation.Labeling review: regarding the issue reported by the customer the ifu section 'mri safety and mri compatibility' states: "safety information for magnetic resonance (mr) procedures (.) pertains to the use of shielded mr systems with (.), gradient magnetic fields of 20-tesla/second or less, (.).".
Event or Problem Description
It was reported that the unit of gradient magnetic field on the packaging insert was allegedly incorrect.There was no reported patient contact.

• Brand Name: FLEXXUS ENDOSCOPIC BILIARY STENT
• Common Device Name: ENDOSCOPIC BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8229606
• Report Number: 9681442-2018-00235
• Device Sequence Number: 19350327
• Product Code: FGE
• UDI-Device Identifier: 00801741099267
• UDI-Public: (01)00801741099267
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LXB08100
• Device Catalogue Number: LXB08100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1