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

Model Number G31903

Device Problem Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Date 03/08/2019

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 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 product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.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

In preparation for a procedure, the user selected two (2) cook fusion omni-tome sphincterotomes.Upon opening, the sphincterotome came out crooked [tip bent in wrong direction] and could not to be used.This incident occurred twice on the same day, on sphincterotomes of the same lot number.[completed procedure with] use of another sphincterotome.This occurred prior to patient contact; there was no impact to the patient.

Manufacturer Narrative

Investigation evaluation: device 1 - our laboratory evaluation of the product said to be involved confirmed the report 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.Device 2 - our laboratory evaluation of the product said to be involved confirmed the report 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 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.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.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 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 two (2) cook fusion omni-tome sphincterotomes.Upon opening, the sphincterotome came out crooked [tip bent in wrong direction] and could not to be used.This incident occurred twice on the same day, on sphincterotomes of the same lot number.[completed procedure with] use of another sphincterotome.This occurred prior to patient contact; there was no impact to the patient.

• 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: 8488538
• MDR Text Key: 141243062
• Report Number: 1037905-2019-00174
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002319035
• UDI-Public: (01)00827002319035(17)220123(10)W4170813
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2022
• Device Model Number: G31903
• Device Catalogue Number: FS-OMNI
• Device Lot Number: W4170813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1