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

Catalog Number FS-OMNI

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/20/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: cook acrobat2 calibrated tip wire guide, awg2-35-260.Cook fusion cytology brush, fs-cb-6.Cook fusion oasis stent, fs-oa-10.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Prior to distribution, all fusion omni-tome sphincterotomes are subjected to a visual inspection and functional test to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered remote.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook fusion omni-tome sphincterotome.The sleeve for the wire port was distal not proximal.This caused additional issues through out the procedure.The black sleeve was in the endoscope and was pushed out into the patients duodenum with a cook fs-oa-10 stent.The sleeve detached in the patient and was retrieved with a rat tooth by the physician.A section of the device did not remain inside the patient¿s body.The detached portion of the sphincterotome was retrieved with a rat tooth during the procedure.While the complainant did not specify if the patient experienced any adverse effects, the information that was able to be collected does not reasonably suggest the patient was adversely impacted.

• Brand Name: FUSION OMNI-TOME
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 9680786
• MDR Text Key: 178107617
• Report Number: 1037905-2020-00064
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-OMNI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• 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
• Treatment: OLYMPUS ERCP ENDOSCOPE