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 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: unknown.Investigation evaluation: a product evaluation was not performed in response to this report because the products said to be involved were 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-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: 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 two (2) cook fusion omni-tome.Sphincterotomes.The tips were bent and the wire could not be loaded.There was no reportable information at this time.Additional information received on (b)(6) 2020 that the tip of the papillotome was bent and it couldn`t be placed correctly in front of the papilla [incorrect cutting wire orientation] [subject of report].The wire could not be tensioned.Our attempts to collect additional information regarding patient outcome were unsuccessful.While the complainant did not specify if the patient 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 was adversely impacted.

Manufacturer Narrative

Initial reporter occupation: unknown.Investigation evaluation: device 1: an evaluation of the device could not confirm 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 1 o¿clock.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 at the distal end, and an unknown red/brown substance was observed near the cutting wire.A discrepancy or anomaly that could have contributed to the reported event was not observed during our laboratory analysis of the returned product.Device 2: 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 10 o¿clock.The device was then bowed and the cutting wire was facing 7 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, and an unknown red/brown substance was observed at the distal tip of the catheter.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 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: 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
• 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: 10532153
• MDR Text Key: 206974445
• Report Number: 1037905-2020-00381
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 10827002319032
• UDI-Public: (01)10827002319032(17)230106(10)W4304118
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2023
• Device Catalogue Number: FS-OMNI
• Device Lot Number: W4304118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE, MAKE AND MODEL UNKNOWN.