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 Problems Migration or Expulsion of Device (1395); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

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.The report could not be confirmed.The device history record for the preloaded wire guide [sub assembly lot number] was reviewed.A discrepancy or anomaly was not observed.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.Evaluation 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 two (2) endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion omni-tome pre-loaded sphincterotome.When the physician removed the sphincterotome from the endoscope, he had great difficulty opening the catheter [difficult zip exchange] which twisted.The wire guide was removed out of the biliary duct [lost wire guide access] and the physician had to use 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.

Event Description

During two (2) endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion omni-tome pre-loaded sphincterotome.When the physician removed the sphincterotome from the endoscope, he had great difficulty opening the catheter [difficult zip exchange] which twisted.The wire guide was removed out of the biliary duct [lost wire guide access] and the physician had to use 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

Continued from section e3 occupation: non-healthcare professional.Investigation evaluation: three products were returned.Of the three products returned, one was the complaint device and two were sealed devices.Our laboratory evaluation of the complaint device confirmed the report.The entire breakthrough channel of the device had been utilized hence a functional test could not be performed on the returned device.The outer edges of the channel showed rippling approximately 38 cm from the distal end indicating difficulty during zip exchange.Fraying was observed in the catheter approximately 42.5 cm and 47.2 cm from the distal end.Several areas of the catheter were bent.A visual examination of the distal end of the device showed that the cutting wire securing component had moved proximal from the intended location.No portion of the sphincterotome device was missing.A discrepancy or anomaly that could have contributed to the reported event was not observed during our laboratory analysis of the returned product.Our laboratory evaluation of the sealed devices could not confirm the report but confirmed it based on an evaluation of the complaint device.Device 1: our laboratory evaluation of sealed device 1 could not confirm the report.During our laboratory analysis, the device was prepped and advanced through a duodenoscope placed in a simulated biliary position.The duodenoscope has an accessory channel that is 4.2 mm in diameter (model number olympus tjf-160vr).The tip of the device was advanced through the papilla and the wire guide was held in place using a wire lock.A zip exchange was successfully performed with the wire guide held in place.Resistance was not encountered during the exchange.A visual examination of the catheter for device 1 showed a small amount of rippling.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.Device 2: our laboratory evaluation of sealed device 2 could not confirm the report.During our laboratory analysis, the device was prepped and advanced through a duodenoscope placed in a simulated biliary position.The duodenoscope has an accessory channel that is 4.2 mm in diameter (model number olympus tjf-160vr).The tip of the device was advanced through the papilla and the wire guide was held in place using a wire lock.A zip exchange was successfully performed with the wire guide held in place.Resistance was not encountered during the exchange.A visual examination of the catheter for device 2 did not show rippling.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.The device history record for the preloaded wire guide [sub assembly lot number] was reviewed.A discrepancy or anomaly was not observed.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 fusion 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/included in the scope 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.

• 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: 7937905
• MDR Text Key: 125132417
• Report Number: 1037905-2018-00470
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002558144
• UDI-Public: (01)00827002558144(17)210716(10)W4091587
• 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: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2021
• Device Catalogue Number: FS-OMNI-35-260
• Device Lot Number: W4091587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Date Manufacturer Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS TJFQ 180V DUODENOSCOPE