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

Catalog Number FS-OMNI

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: an evaluation of the device confirmed the report of incorrect cutting wire orientation.During our laboratory analysis, the sphincterotome was advanced through a duodenoscope that was placed in a simulated biliary position.The duodenoscope has an accessory channel that is 4.2 mm in diameter (olympus model number tjf-160v).The catheter exited the endoscope with the cutting wire facing 9 o¿clock.The device was then bowed and the cutting wire was facing 10 o'clock (appropriate orientation is approximately 11:00 - 1:00 o'clock).The sphincterotome catheter was subjected to a close visual examination and twisting of the tubing was observed at the distal end.Liquid was also observed inside of the catheter and an unknown yellow substance was observed at the distal tip.A discrepancy or anomaly that could have contributed to the reported event was not observed during our laboratory analysis of the returned product.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.A factor that can contribute to improper cutting wire orientation includes manipulating the handle with the catheter in a coiled position or with the precurved stylet inside the cannulating tip.The instructions for use advise the user: "upon removing device from package, uncoil and straighten sphincterotome." the user is then instructed to: "carefully remove precurved stylet from cannulating tip." the instructions for use contain the following comment: "note: do not exercise handle while device is coiled or precurved stylet is in place, as this may cause damage to sphincterotome and render it inoperable." prior to distribution, all fusion omni-tomes are subjected to a visual inspection and functional testing 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: 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.The physician tried to cut the ampulla but found that the cutting wire orientation was bad [more than 1 o'clock].The fs-omni was removed and another one from the same lot was used.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook fusion omni-tome.The physician tried to cut the ampulla but found that the cutting wire orientation was bad [more than 1 o'clock].The fs-omni was removed and another one from the same lot was used.Additional information was received on 21-august-2020 which states that the distal end of the catheter was formed manually.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation evaluation: an evaluation of the device confirmed the report of incorrect cutting wire orientation.During our laboratory analysis, the sphincterotome was advanced through a duodenoscope that was placed in a simulated biliary position.The duodenoscope has an accessory channel that is 4.2 mm in diameter (olympus model number: tjf-160v).The catheter exited the endoscope with the cutting wire facing 9 o¿clock.The device was then bowed and the cutting wire was facing 10 o'clock (appropriate orientation is approximately 11:00 - 1:00 o'clock).The sphincterotome catheter was subjected to a close visual examination and twisting of the tubing was observed at the distal end.Liquid was also observed inside of the catheter and an unknown yellow substance was observed at the distal tip.A discrepancy or anomaly that could have contributed to the reported event was not observed during our laboratory analysis of the returned product.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: this type of damage can occur if the distal end of the catheter is shaped manually.The additional information in the "patient / event info - notes" states that the distal end of the device was manually formed.This sphincterotome catheter is pre-curved and is provided with a pre-curved stylet in the distal tip of the catheter.This obviates the need for manual formation.The instructions for use contain the following comment: ¿note: do not apply manual pressure to tip or cutting wire of sphincterotome to influence orientation, as this may result in damage to device.¿ this is a likely cause for the reported observation.Prior to distribution, all fusion omni-tomes sphincterotomes are subjected to a visual inspection and functional testing 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: 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.Additional comments regarding this report: based on the information provided that the distal end of the catheter was formed manually, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• 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
• MDR Report Key: 10413182
• MDR Text Key: 234399907
• Report Number: 1037905-2020-00327
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 10827002319032
• UDI-Public: (01)10827002319032(17)230316(10)W4330636
• Combination Product (y/n): N
• PMA/PMN Number: K052051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2023
• Device Catalogue Number: FS-OMNI
• Device Lot Number: W4330636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ELECTROSURGICAL GENERATOR, MAKE AND MODEL UNKNOWN; OLYMPUS TJF260, ENDOSCOPE; VISIGLIDE 0.025, MAKE UNKNOWN