MAUDE Adverse Event Report: COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number ASDB-15-015-S

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

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 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.A corrective action has been initiated to reduce occurrences for snare head retraction difficulties for acusnare polypectomy snare devices.The product said to be involved is included in the scope of the corrective actions.Prior to distribution, all acusnare polypectomy snares are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.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 polypectomy, the physician used a cook acusnare polypectomy snare.The snare twisted during use.The loop [snare head] could be opened, [but then the snare head] twisted.Catching the polyp was not possible [because] the twisting was very strong.The user tried to pull back the loop [snare head] but it was difficult [difficult retraction].The snare was completely removed, and there was no product damage or patient injury.The procedure was completed with a new 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

Continued from section e3 occupation: non-healthcare professional.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The snare was returned with the snare head retracted into the sheath.When the handle of the device was manipulated, the snare head would not advance.A visual inspection of the snare head found the snare head was misshaped and was preventing the snare head from extending outside the sheath.The sheath was removed from the device so that the snare head could be investigated.The snare head was confirmed to be misshaped.The sheath of the snare was disassembled from the handle to evaluate the formed snare wire.It was found during the evaluation of the snare wire cannula, that is soldered to the snare wire, was in the correct location.The cannula on the complaint device was measured and does meet the requirement.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 corrective action has been initiated to reduce occurrences for snare head retraction difficulties for acusnare (asdb) devices.The product said to be involved is included in the scope of the corrective actions.Prior to distribution, all acusnare polypectomy snares are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation in the scope of this corrective action.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 polypectomy, the physician used a cook acusnare polypectomy snare.The snare twisted during use.The loop [snare head] could be opened, [but then the snare head] twisted.Catching the polyp was not possible [because] the twisting was very strong.The user tried to pull back the loop [snare head] but it was difficult [difficult retraction].The snare was completely removed, and there was no product damage or patient injury.The procedure was completed with a new 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.

• Brand Name: ACUSNARE POLYPECTOMY SNARE
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8232271
• MDR Text Key: 132644038
• Report Number: 1037905-2019-00010
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002226470
• UDI-Public: (01)00827002226470(17)210918(10)W4121022
• Combination Product (y/n): N
• PMA/PMN Number: K851958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2021
• Device Catalogue Number: ASDB-15-015-S
• Device Lot Number: W4121022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS CV-190 ENDOSCOPE