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Model Number G22649
Device Problem Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2021
Event Type  malfunction  
Manufacturer Narrative
Information regarding pma/510(k): k191048. Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report. The label matches the product returned. The photos provided are of the same reference part number with the snare advanced, however the lot number does not match the report. Our laboratory evaluation of the product said to be involved could not confirm the report for unable to advance. The device was returned fully retracted with a dried brown/red substance on the package and on/inside the device. The handle was manipulated and the snare was advanced out of the sheath. The snare appeared misshapen and deformed with a burnt look to the wire. The snare could not be fully retracted when the handle was manipulated. 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. Although difficulty advancing could not be confirmed as the customer reported, we were able to confirm difficulty retracting. 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: a review of the complaint history was conducted. The likelihood of occurrence is considered rare. 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 a esophagogastroduodenoscopy with cleaning out of pancreatic pseudocyst , the physician used a cook acusnare polypectomy snare. It was initially reported that the snare wire would not come out of the sheath when they did the second pass with the device. Here was no reportable information at this time. Our evaluation of the returned device on (b)(6) 2021, determined that the snare was advanced from the sheath but would not fully retract when handle was manipulated [subject of the report]. 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.
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Manufacturer (Section D)
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
kaylin davis
4900 bethania station rd
winston-salem, NC 27105
MDR Report Key11693418
MDR Text Key267663555
Report Number1037905-2021-00160
Device Sequence Number1
Product Code FDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG22649
Device Catalogue NumberASDB-25-015-S
Device Lot NumberW4348842
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial