MAUDE Adverse Event Report: COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE; FDI, SNARE, FLEXIBLE

Model Number G22647

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k191048.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.The device history record contains non-conformances that could potentially be related to this report.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.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 instructions for use direct the user to: "fully retract and extend snare to confirm smooth operation of device." damage to the product can occur if the device experiences excessive pressure during use.Prior to distribution, all acusnare polypectomy snares are subjected to a visual inspection.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 Description

During an endoscopic polypectomy, the physician used a cook acusnare polypectomy snare.The housing over the snare wire, near the handle, was buckling or wrinkling.It was not closing effectively.Then it would snap shut.The procedure was successfully completed with a different crescent snare.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

Investigation evaluation: the product said to be involved was returned in a plastic pouch with no lot number.Our laboratory evaluation of the product said to be involved confirmed the report.During a visual evaluation of the returned device, the snare head was retracted.At the distal end of the handle, the catheter is collapsing due to the force of retracting the snare head and is severely kinked.During a functional test, the handle of the device was manipulated, the snare head would not advance and retract as intended.There was a lot of resistance, and occasionally the snare head would get stuck halfway during retraction.The resistance caused further damage to the catheter by the distal end of the handle.The distal end of the snare was viewed under magnification and appears to be within specification.A laboratory meeting was held with manufacturing and engineering; no anomalies were detected with the device construction.The device history record for the lot number said to be involved was reviewed.The device history record contains non-conformances that could potentially be related to this report.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.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.The instructions for use direct the user to: "fully retract and extend snare to confirm smooth operation of device." damage to the product can occur if the device experiences excessive pressure during use.Prior to distribution, all acusnare polypectomy snares are subjected to a visual inspection.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: ACUSNARE POLYPECTOMY SNARE
• Type of Device: FDI, SNARE, FLEXIBLE
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 10985840
• MDR Text Key: 247019113
• Report Number: 1037905-2020-00545
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 00827002226470
• UDI-Public: (01)00827002226470(17)230507(10)W4346126
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2023
• Device Model Number: G22647
• Device Catalogue Number: ASDB-15-015-S
• Device Lot Number: W4346126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS PCF-PH190L ENDOSCOPE
• Patient Age: 73 YR