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

Model Number	G31911
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The report could not be confirmed.The device history record for the lot number said to be involved was reviewed.A nonconformance that could potentially be related to the complaint was observed in the device history record.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 tubing became twisted at the distal end.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 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: 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 or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion omni-tome pre-loaded sphincterotome.The sphincterotome behaved in an unusual and twisting manner.This made correct orientation impossible, in and out of the body.He tried to manipulate the unnatural curve in his hand without success.The sphincterotome was replaced by a cook fusion omni-tome sphincterotome, which worked perfectly and was a successful ercp.The following additional information was received on 01-feb-2019 from the distribution partner: the sphincterotome was out of the endoscope approximately four (4) cm.It appeared to have a slightly strange orientation prior to entry into the endoscope.On bowing, it [incorrect cutting wire orientation] was much more severe.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 or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion omni-tome pre-loaded sphincterotome.The sphincterotome behaved in an unusual and twisting manner.This made correct orientation impossible, in and out of the body.He tried to manipulate the unnatural curve in his hand without success.The sphincterotome was replaced by a cook fusion omni-tome sphincterotome, which worked perfectly and was a successful ercp.The following additional information was received on 01-feb-2019 from the distribution partner: the sphincterotome was out of the endoscope approximately four (4) cm.It appeared to have a slightly strange orientation prior to entry into the endoscope.On bowing, it [incorrect cutting wire orientation] was much more severe.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.
Additional Manufacturer Narrative
Continued from section e3 occupation: non-healthcare professional.Investigation evaluation: an evaluation of the returned device confirmed the report of incorrect cutting wire orientation.During our laboratory analysis, the sphincterotome was advanced through a duodenoscope that was placed in a simulated biliary position.The duodenoscope has an accessory channel that is 4.2 mm in diameter (olympus model number tjf-160v).The catheter exited the endoscope with the cutting wire facing 6 o¿clock.The device was then bowed and the cutting wire was facing 3 o'clock (appropriate orientation is approximately 11:00 - 1:00 o'clock).The sphincterotome catheter was subjected to a close visual examination and twisting of the tubing was observed at the distal end.The device history record for the lot number said to be involved was reviewed.A nonconformance that could potentially be related to the complaint was observed in the device history record.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 tubing became twisted at the distal end.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.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: 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
• Common Device Name: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8361532
• Report Number: 1037905-2019-00083
• Device Sequence Number: 16670589
• Product Code: KNS
• UDI-Device Identifier: 00827002319110
• UDI-Public: (01)00827002319110(17)191013(10)W3778279
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K052051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2019
• Device Model Number: G31911
• Device Catalogue Number: FS-OMNI-35
• Device Lot Number: W3778279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS ENDOSCOPE, UNKNOWN MODEL; OLYMPUS ENDOSCOPE, UNKNOWN MODEL