MAUDE Adverse Event Report: COOK ENDOSCOPY ACROBAT¿ CALIBRATED TIP WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	G34266
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cook fusion omni-tome sphincterotome, fs-omni.Occupation: non-healthcare professional.Investigation evaluation: a product evaluation was performed only by the photos provided with this report because the product said to be involved was not provided to cook for evaluation.The lot number provided in the photo of the label matches this report.The label in the photo matches the product reported.The report was confirmed with the photo provided of the product.In the photo, bare core wire can be seen where the distal end of the wire is coiled.Distal to the bare core wire appears to be approximately 3 cm of coating that is hanging off the wire.There also appears to be damage at approximately the 7 cm marking.The wire guide is kinked at approximately the 4 cm marking.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.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 cook acrobat calibrated tip wire guides 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: 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 a procedure, the physician used a cook acrobat calibrated wire guide.Per the photo provided, the device appeared to have coating damage.The coating of the wire guide peeled off at the patient end during the procedure.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 a procedure, the physician used a cook acrobat calibrated wire guide.Per the photo provided, the device appeared to have coating damage.The coating of the wire guide peeled off at the patient end during the procedure.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
This correction follow up report is being sent to correct date of event.Cook fusion omni-tome sphincterotome, fs-omni; occupation: non-healthcare professional.Investigation evaluation: a product evaluation was performed only by the photos provided with this report because the product said to be involved was not provided to cook for evaluation.The lot number provided in the photo of the label matches this report.The label in the photo matches the product reported.The report was confirmed with the photo provided of the product.In the photo, bare core wire can be seen where the distal end of the wire is coiled.Distal to the bare core wire appears to be approximately 3 cm of coating that is hanging off the wire.There also appears to be damage at approximately the 7 cm marking.The wire guide is kinked at approximately the 4 cm marking.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.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 cook acrobat calibrated tip wire guides 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 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.
Additional Manufacturer Narrative
Cook fusion omni-tome sphincterotome, fs-omni.Occupation: non-healthcare professional.Investigation evaluation: photos were provided in response to this report.The first photo contains the wire guide pouch and the lot number associated with this report.In the second photo, bare core wire can be seen where the distal end of the wire is coiled.Distal to the bare core wire appears to be approximately 3 cm of coating that is hanging off the wire.There also appears to be damage at approximately the 7 cm marking.The wire guide is kinked at approximately the 4 cm marking.Our evaluation of the product said to be involved confirmed the report.The wire guide is kinked approximately 9.0 cm from the distal end.The wire guide appears accordioned approximately 11.8 cm to 12.8 cm from the distal end.Approximately 11.8 cm to 12.5 cm from the distal end, the wire guide covering is twice folded over.Approximately 12.5 cm to 18.9 cm from the distal end, the wire guide covering has folded over itself once.The folded over portion of covering is split at approximately 15.7 cm to 18.6 cm from the distal end.A section of the coating approximately 0.4 cm long is hanging from the wire guide, the coating still attached at approximately 12.5 cm from the distal end.Approximately 18.9 cm to 26.9 cm from the distal end is a section of bare core wire.The wire guide coating is stretched thin at approximately 26.9 cm to 28.0 cm.The wire guide covering feels rough approximately 228.0 cm to 231.8 cm and 291.1 cm to 294.0 cm from the distal end.Due to the condition of the returned device it cannot be determined if any sections of the coating are missing.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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 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 cook acrobat calibrated tip wire guides 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 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 a procedure, the physician used a cook acrobat calibrated wire guide.Per the photo provided, the device appeared to have coating damage.The coating of the wire guide peeled off at the patient end during the procedure.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 a procedure, the physician used a cook acrobat calibrated wire guide.Per the photo provided, the device appeared to have coating damage.The coating of the wire guide peeled off at the patient end during the procedure.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
This correction follow up report is being sent to correct date of this report from 20-mar-2019 to 21-mar-2019.Cook fusion omni-tome sphincterotome, fs-omni.Occupation: non-healthcare professional.Investigation evaluation: a product evaluation was performed only by the photos provided with this report because the product said to be involved was not provided to cook for evaluation.The lot number provided in the photo of the label matches this report.The label in the photo matches the product reported.The report was confirmed with the photo provided of the product.In the photo, bare core wire can be seen where the distal end of the wire is coiled.Distal to the bare core wire appears to be approximately 3 cm of coating that is hanging off the wire.There also appears to be damage at approximately the 7 cm marking.The wire guide is kinked at approximately the 4 cm marking.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.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 cook acrobat calibrated tip wire guides 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 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: ACROBAT¿ CALIBRATED TIP WIRE GUIDE
• Common Device Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8506067
• Report Number: 1037905-2019-00189
• Device Sequence Number: 13855928
• Product Code: OCY
• UDI-Device Identifier: 00827002342668
• UDI-Public: (01)00827002342668(17)211009(10)W4129360
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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,Followup,Followup
• Report Date (Section B): 03/21/2019

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: 10/09/2021
• Device Model Number: G34266
• Device Catalogue Number: ACRO-35-450
• Device Lot Number: W4129360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 03/20/2019; 03/20/2019; 03/20/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/06/2019; 06/05/2019; 06/27/2019
• 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 TJF-260 ENDOSCOPE.