MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. MORAY MICRO FORCEPS

Model Number	00711889
Health Effect - Clinical Code	Pancreatitis (4481)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user of the device stated that pancreatitis could be caused by the fna needle.The device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.Statements from the instructions for use include: "if using the device through an fna needle, make sure to maintain eus visualization of forceps at all times during usage.Losing visualization of forceps may allow the end user to advance forceps too far, potentially injuring surrounding tissue or structures.The risks associated with using this device through an fna needle under eus guidance are similar to the risks incurred when standard eus fna is performed." the device subject of this complaint is not available for evaluation.The user of the device has declined further communication regarding this event.No further issues have been reported.
Event or Problem Description
The distributor reported that a patient developed pancreatitis following a procedure which included use of the moray micro forceps through a 19g fna needle for sampling a pancreatic cyst.The user of the device has declined to provide patient status or treatment information beyond the development on pancreatitis.

• Brand Name: MORAY MICRO FORCEPS
• Common Device Name: FORCEPS
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 11571051
• Report Number: 1528319-2021-00011
• Device Sequence Number: 11828654
• Product Code: FCL
• UDI-Device Identifier: 00724995184094
• UDI-Public: (01)00724995184094
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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: Health Professional
• Device Expiration Date: 08/25/2023
• Device Model Number: 00711889
• Device Catalogue Number: 00711889
• Device Lot Number: 2008084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1