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

Model Number G48676

Device Problems Peeled/Delaminated (1454); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: olympus ercp processor.Occupation: non-healthcare professional.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.A photo was provided and reviewed.An evaluation of the photo provided confirmed the report.The photo shows the wire guide in the sphincterotome.Wire guide coating appears to have peeled, exposing bare core wire in a portion of the wire guide.We were unable to determine the exact location of damage based on the photo.Without return of the complaint device a complete evaluation could not be performed.The sub assembly device history record for the wire guide was reviewed.A discrepancy or anomaly was not observed.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.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide coating damage.Prior to distribution, all fusion omni-tome pre-loaded sphincterotomes are subjected to a visual inspection to ensure device integrity.A definitive cause for the reported observation could not be determined.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is currently being assessed and a follow up report will be sent.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), the physician used a fusion omni-tome pre-loaded sphincterotome.The coating of the wire guide stripped and the wire guide got stuck in the sphincterotome.There was no spare wire guide.The entire pre-loaded sphincterotome was replaced and the operation continued without other difficulty or delay [lost wire guide access] [subject of this report].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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a fusion omni-tome pre-loaded sphincterotome.The coating of the wire guide stripped and the wire guide got stuck in the sphincterotome.There was no spare wire guide.The entire pre-loaded sphincterotome was replaced and the operation continued without other difficulty or delay lost wire guide access subject of this report.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

Continued from concomitant medical products: olympus ercp processor.Initial reporter occupation: non-healthcare professional.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.A photo was provided and reviewed.An evaluation of the photo provided confirmed the report.The photo shows the wire guide in the sphincterotome.Wire guide coating appears to have peeled, exposing bare core wire in a portion of the wire guide.We were unable to determine the exact location of damage based on the photo.Without return of the complaint device a complete evaluation could not be performed.The sub assembly device history record for the wire guide was reviewed.A discrepancy or anomaly was not observed.The device history record does contain a nonconformance that could potentially be related to the complaint.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to 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.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide coating damage.Prior to distribution, all fusion omni-tome pre-loaded sphincterotomes are subjected to a visual inspection to ensure device integrity.A definitive cause for the reported observation could not be determined.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.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), the physician used a fusion omni-tome pre-loaded sphincterotome.The coating of the wire guide stripped and the wire guide got stuck in the sphincterotome.There was no spare wire guide.The entire pre-loaded sphincterotome was replaced and the operation continued without other difficulty or delay [lost wire guide access] [subject of this report].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

Continued from section d.11.Concomitant products: olympus ercp processor.Section e.3.Occupation: non-healthcare professional.Investigation evaluation: a device was received for evaluation on 15-nov-2019 with a reference number on the pouch for a separate complaint record.On receiving clarification that the complaint product was associated with this report, the investigation was updated and completed on 07-apr-2020.The lot number could not be confirmed because a lot number was not included in the return.The label matches the product returned.A photo was provided and reviewed.An evaluation of the photo provided confirmed the report.The photo shows the wire guide in the sphincterotome.Wire guide coating appears to have peeled, exposing bare core wire in a portion of the wire guide in the spiral coating.Our evaluation of the product said to be involved confirmed coating damage to the proximal end of the wire guide.A functional test could not be performed on the returned device.The preloaded wire guide was returned stuck in the sphincterotome.There is wire guide coating damage present on the wire guide stuck in the sphincterotome.The wire guide was stuck in the sphincterotome approximately 275 cm from the proximal end of the wire guide.We were unable to determine if a portion of wire guide coating was missing due to the condition of the returned device.Wire guide coating had peeled and accordioned on the core wire approximately 270 cm from the proximal end of the wire guide.A portion of the distal end of the wire guide was stuck inside the sphincterotome, hence a determination of the extent of wire guide damage could not be performed.The sub-assembly device history record for the wire guide was reviewed.A discrepancy or anomaly was not observed.The device history record contains a nonconformance that could potentially be related to the complaint.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to 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.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide coating damage.Prior to distribution, all fusion omni-tome pre-loaded sphincterotomes are subjected to a visual inspection 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 review of the complaint history was conducted.The likelihood of occurrence is considered rare.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: 9312623
• MDR Text Key: 219780737
• Report Number: 1037905-2019-00694
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002486768
• UDI-Public: (01)00827002486768(17)220129(10)W4172724
• Combination Product (y/n): N
• PMA/PMN Number: K052051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2022
• Device Model Number: G48676
• Device Catalogue Number: FS-OMNI-21-480
• Device Lot Number: W4172724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Date Manufacturer Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS TJFQ180V DUODENOSCOPE