MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION WIRE GUIDE LOCKING DEVICE; OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number	FS-WL-O-S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical devices: ocy, endoscope and accessories.Investigation evaluation: 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.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 wire guide locking devices 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 and this represents an unusual occurrence.The likelihood of occurrence is considered remote.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
A medwatch report mw5073533 was received on 12/11/2017: the patient was undergoing endoscopic retrograde cholangiopancreatography (ercp) and it was noted that a sponge was in the biopsy channel from a previous procedure.It is believed that the sponge material machines [matches] that of the biopsy cap.The scope was removed and new scope was utilized.The patient required no further treatment.Additional information was received on 01/03/2017: the reporters were not certain if the locking device was from cook.It was quite possibly [the boston scientific] locking device because they use both.The reporter said she has sent all the information to risk management.
Additional Manufacturer Narrative
Correction to common device name is being corrected to endoscopic guidewire, gastroenterology-urology and procode is being corrected to ocy.Investigation evaluation: 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.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.The user stated that a water soluble lubricant was not used.This could have possibly contributed to the wire lock becoming displaced.The instructions for use states, "apply water-soluble lubricant to top of cap as needed to ease passage of accessories." prior to distribution, all fusion wire guide locking devices 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 and this represents an unusual occurrence.The likelihood of occurrence is considered remote.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
The following was initially provided on 01/05/2018: "a medwatch report mw5073533 was received on 12/11/2017: the patient was undergoing endoscopic retrograde cholangiopancreatography (ercp) and it was noted that a sponge was in the biopsy channel from a previous procedure.It is believed that the sponge material machines [matches] that of the biopsy cap.The scope was removed and new scope was utilized.The patient required no further treatment.Additional information was received on 01/03/2017: the reporters were not certain if the locking device was from cook.It was quite possibly [the boston scientific] locking device because they use both.The reporter said she has sent all the information to risk management.Additional information was received on 01/09/2018: the sponge was discovered in the biopsy channel.The endoscope was immediately removed from service and another ercp endoscope was used.

• Brand Name: FUSION WIRE GUIDE LOCKING DEVICE
• Common Device Name: OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7167952
• Report Number: 1037905-2018-00003
• Device Sequence Number: 16377022
• Product Code: OCY
• UDI-Device Identifier: 00827002315228
• UDI-Public: (01)00827002315228(17)200418(10)W3854576
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018
• Report Date (Section F): 11/24/2017

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 Catalogue Number: FS-WL-O-S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/17/2017
• Device Age: 8 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 02/02/2018
• 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: ENDOSCOPE - UNKNOWN MAKE AND MODEL; OLYMPUS TJF-Q180V ENDOSCOPE
• Date Report Sent to FDA: 11/24/2017