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

Catalog Number FS-OMNI

Device Problems Failure to Align (2522); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 03/03/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: an evaluation of the photo provided by the user confirmed the report of incorrect cutting wire orientation. Twisting of the cutting wire and tubing was observed at the distal end. Our laboratory evaluation of the product said to be involved confirmed the report of incorrect cutting wire orientation, based on the condition of the distal end of the returned device. A visual examination of the cutting wire showed twisting at the distal end. The distal end does not represent the shape at the time of manufacture. The device goes through several different inspections in manufacturing, final quality control, and packaging departments prior to leaving the facility in an effort to ensure proper orientation. Therefore, it is unknown how, or at what point, the cutting wire became twisted at the distal end. The nonconformance information documented 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 prior to use testing conditions could not be duplicated in the laboratory setting. This limits our ability to conclusively determine a cause. A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product. Improper cutting wire orientation can occur if the distal end of the catheter is shaped manually. This sphincterotome catheter is precurved and is provided with a precurved 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. ¿ other factors that can contribute to improper cutting wire orientation include 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. 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. The nonconformance documented 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. 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

In preparation for a procedure, the user selected a cook fusion omni-tome sphincterotome. The operator opened the package and checked the device. [the user] found out the orientation of the cutting wire was seriously deviated [incorrect cutting wire orientation].

• 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 Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7382784
• MDR Text Key: 104150941
• Report Number: 1037905-2018-00122
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K052051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/29/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: FS-OMNI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/03/2018
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial