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

Model Number 00711889

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 09/14/2016

Event Type  Injury  

Manufacturer Narrative

The disposable moray micro forceps is a sterile device intended to sample tissue from lesions that can occur within and outside the gastrointestinal tract (e.G.Pancreas).Us endoscopy received a report of an infection following an eus fna procedure utilizing an fna needle initially to gain pancreatic access through the peritoneum and subsequent use of the moray microforceps once pancreatic access was made.The infection was treated by marsupialization of the cyst.A fna needle was used to access the cyst through a thick wall and a moray micro forceps was used to sample from a thick wall.The infection was treated by marsupialization of the cyst.The patient recovered in the hospital and was released.The physician stated it is unknown if the infection was connected to use of the moray micro forceps.The device was not returned for evaluation.The device history record was reviewed and found all in-process and final inspections were completed and acceptable results were documented.There was no indication that the device malfunctioned.This report will be updated if additional information becomes available.Not returned to manufacturer.

Event Description

The disposable moray micro forceps is a sterile device intended to sample tissue from lesions that can occur within and outside the gastrointestinal tract (e.G.Pancreas).Us endoscopy received a report of an infection following an eus fna procedure utilizing an fna needle initially to gain pancreatic access through the peritoneum and subsequent use of the moray microforceps once pancreatic access was made.The infection was treated by marsupialization of the cyst.A fna needle was used to access the cyst through a thick wall and a moray micro forceps was used to sample from a thick wall.The infection was treated by marsupialization of the cyst.The patient recovered in the hospital and was released.The physician stated it is unknown if the infection was connected to use of the moray micro forceps.

• Brand Name: MORAY MICRO FORCEPS
• Type of Device: BIOPSY FORCEPS
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 6045235
• MDR Text Key: 58016848
• Report Number: 1528319-2016-00028
• Device Sequence Number: 1
• Product Code: FCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: 00711889
• Device Catalogue Number: 00711889
• Device Lot Number: 1609470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization