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

Catalog Number FS-OMNI-21-480

Device Problem Migration or Expulsion of Device (1395)

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

Event Type  malfunction  

Manufacturer Narrative

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.The device history record for the lot number said to be involved could not be reviewed because a 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.The instructions for use instruct the user to do the following: "for best results, wire guide should be kept wet." failure to flush the wire guide can result in damage to the wire guide.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide coating damage.Prior to distribution, all fusion omni-tome pre-loaded sphincterotomes are subjected to a visual inspection 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.The likelihood of occurrence is considered rare.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), the physician used three (3) cook fusion omni-tome pre-loaded sphincterotomes.Upon cannulating [attempting to], they used the device to cannulate with the wire guide that was provided but could not cannulate, so they removed that wire guide and put in another manufacturer's wire guide.They were able to cannulate, but other manufacturer's wire guide was too floppy, so it was taken out [of the sphincterotome] and the cook wire guide that comes with it [the pre-loaded wire guide] was reused.They got "where they needed to go," but when the doctor went to remove [the sphincterotome], the sphincterotome caught the wire guide and the wire guide would not come back or go forward [difficult exchange].It was stuck in place.At that point, they attempted to wiggle [the device], and there was no progress.The wire guide kept shredding (outer coat) as force was applied forward or backwards [coating damage].The entire device had to be pulled out, and it lost the physician's cannulation [lost wire guide access, see related mdr 1037905-2018-00366].This was the first device.They attempted to use another omni-tome.It was a similar situation, but they did not wait for it [the wire guide] to shred before removing the product (second device) [also subject of this report].A third attempt resulted in same result as the second device, but at that point there was too much edema [swelling], so the procedure was aborted after around 2.5 hours (third device) [see related mdr 1037905-2018-00366].The following was received on 08/07/2018: per the customer, "this isn¿t the first time that we have this issue with this sphincterotome.It happens quite frequently we just do not report it to your company every time that it does (subject of this report)." our attempts to collect additional information regarding patient outcomes were unsuccessful.While the complainant did not specify if the patients experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient s were adversely impacted.

• Brand Name: FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME
• 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: 7839594
• MDR Text Key: 119654102
• Report Number: 1037905-2018-00369
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-OMNI-21-480
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2018
• 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