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

Catalog Number FS-OMNI-35-260

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical product: erbe electrosurgical generator.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 evaluation: a corrective action has been initiated to reduce occurrences of stripping difficulty for omni sphincterotomes.The product said to be involved is included in the scope of the corrective actions.Prior to distribution, all fusion omni-tome pre-loaded 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: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.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 a sphincterotomy, the physician used a cook fusion omni-tome pre-loaded sphincterotome.The peeling of the catheter was very bad [difficulty splitting].They needed to use a new product.There was no reportable information at this time.Complaint form received on (b)(6) 2018: after cutting the papilla, they tried to do the exchange.It was not possible to do the peeling correctly.They lost the wire [lost wire guide access] and they needed to recannulate with another sphincterotome.

Manufacturer Narrative

This report is being sent to correct date received by manufacturer, which was incorrectly omitted.The section is be corrected from blank to 20-jul-2018.Continued from section concomitant medical product: erbe electrosurgical generator.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The entire breakthrough channel had been utilized and the associated wire guide was not included in the return which made it difficult to perform a complete functional test.During a visual examination, it was observed that the catheter had ripples in several areas confirming difficulty during exchange.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 corrective action has been initiated to reduce occurrences of stripping difficulty for omni sphincterotomes.The product said to be involved is included in the scope of the corrective actions.Prior to distribution, all fusion omni-tome pre-loaded 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: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.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 a sphincterotomy, the physician used a cook fusion omni-tome pre-loaded sphincterotome.The peeling of the catheter was very bad [difficulty splitting].They needed to use a new product.There was no reportable information at this time.Complaint form received on 08-jun-2018: after cutting the papilla, they tried to do the exchange.It was not possible to do the peeling correctly.They lost the wire [lost wire guide access] and they needed to re-cannulate with another sphincterotome.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

Correction to section b5: this report is being sent to correct section b5 description of event to include the patient outcome.Concomitant medical products: erbe electrosurgical generator.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The entire breakthrough channel had been utilized and the associated wire guide was not included in the return which made it difficult to perform a complete functional test.During a visual examination, it was observed that the catheter had ripples in several areas confirming difficulty during exchange.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 corrective action has been initiated to reduce occurrences of stripping difficulty for omni sphincterotomes.The product said to be involved is included in the scope of the corrective actions.Prior to distribution, all fusion omni-tome pre-loaded 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: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.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 a sphincterotomy, the physician used a cook fusion omni-tome pre-loaded sphincterotome.The peeling of the catheter was very bad [difficulty splitting].They needed to use a new product.There was no reportable information at this time.Complaint form received on (b)(6) 2018: after cutting the papilla, they tried to do the exchange.It was not possible to do the peeling correctly.They lost the wire [lost wire guide access] and they needed to re-cannulate with another sphincterotome.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.

• 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: 7656315
• MDR Text Key: 113288878
• Report Number: 1037905-2018-00293
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002558144
• UDI-Public: (01)00827002558144(17)210207(10)W4025617
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2021
• Device Catalogue Number: FS-OMNI-35-260
• Device Lot Number: W4025617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Date Manufacturer Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS 190 DUODENOSCOPE.