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

Model Number G31911

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: unknown.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 was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: we could not conduct a complete investigation because the products said to be involved were not returned for evaluation.A definitive cause for the reported observation could not be determined.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.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 pre-loaded sphincterotome.The tip looked "odd" prior to use and it was clearly disorientated when it came into endoscopic view.The tip initially pointed at approximately 1 o'clock, but when the catheter was advanced it twisted to 9 o'clock.A new device was opened and used to continue.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

Initial reporter occupation: unknown.Investigation evaluation: our evaluation of the returned 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 10 o¿clock.Prior to being bowed, the distal end entered the simulated papilla.The device was then bowed and the cutting wire was facing 12 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, and the cutting wire had a slight bend in it.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-tome 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.

• 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
• MDR Report Key: 10978990
• MDR Text Key: 247019023
• Report Number: 1037905-2020-00540
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002319110
• UDI-Public: (01)00827002319110(17)230203(10)W4315368
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2023
• Device Model Number: G31911
• Device Catalogue Number: FS-OMNI-35
• Device Lot Number: W4315368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK ACROBAT WIRE GUIDE, AWG2-35-450; OLYMPUS DUODENOSCOPE, 190