MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION OMNI-TOME SPHINCTEROTOME; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number FS-OMNI

Device Problem Mechanics Altered (2984)

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

Event Date 07/28/2015

Event Type  malfunction  

Event Description

Product did not have a hole where it was supposed to be to allow the wire to pass through the device.Another device obtained and procedure continued.No patient harm.

• Brand Name: FUSION OMNI-TOME SPHINCTEROTOME
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station road; winston-salem NC 27105
• MDR Report Key: 5010418
• MDR Text Key: 23259686
• Report Number: 5010418
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/01/2018
• Device Model Number: FS-OMNI
• Device Catalogue Number: G31903
• Device Lot Number: W3573053
• Other Device ID Number: 00827002319035(17)180500(10)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1