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

Catalog Number ASDB-25-015-S

Device Problem Retraction Problem (1536)

Patient Problems Hemorrhage/Bleeding (1888); Hemostasis (1895)

Event Date 08/30/2018

Event Type  Injury  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The snare was returned with the snare head retracted inside the distal end of the sheath.The handle of the device was manipulated to advance the snare head, and when the snare head was advanced outside the sheath, the snare head was misshaped.The snare head did not form a uniform duck bill.When the snare head was advanced outside the sheath, the snare wire was bent above where the duck bill is normally formed.This created two (2) bends in the snare wire.One (1) that is made to create the duck bill shape, and one (1) that was bent during use; thus creating a misshaped snare head.When the handle of the device was manipulated, difficulty was encountered while advancing and retracting the snare head.The misshaped snare head most likely contributed to difficulty advancing and retracting the snare head.A visual inspection of the very distal end of the sheath found that the sheath tubing was slightly distorted, most likely from the snare head being misshaped while it was being retracted into the sheath.The snare wire was manipulated with a pair of tweezers and formed back into a duck bill snare with one (1) bend in the distal end of the wire.The snare head smoothly advanced and retracted when manipulating the handle.When the snare head was fully retracted inside the sheath, the snare head was 26.5 mm from the distal end of the sheath, which meets specification.The sheath of the snare was disassembled from the handle to evaluate the formed snare wire.It was found that snare wire cannula that is soldered to the snare wire was not in the correct location.The position of this cannula could have contributed to the snare head becoming misshaped during use.The cannula on the complaint device was measured at 4.8 cm from the distal end of the snare wire, which does not 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: the investigation determined that the device did not meet manufacturing specification.During the manufacturing process for the forming wire, the cannula was not placed at the correct location prior to being soldered to the forming wire.The operators were retrained on the manufacturing process.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 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 colonoscopic resection of a polyp, the physician used a cook acusnare polypectomy snare.The device stuck to the tissue and was unable to complete full resection of the polyp.The device was removed.There was bleeding.Further information was received by cook product management on 30-august-2018: "[the physician] had a major malfunction during resection of a polyp with a 25 mm cook duckbill acusnare.I believe this was in the colon.This malfunction resulted in a serious adverse event - bleeding." the following was received on 17-september-2018: the bleeding was stopped with another manufacturer's hemostasis clip.A section of the device did not remain inside the patient¿s body.A hemostasis clip was used due to this occurrence.According to the initial reporter, the patient experienced bleeding due to this occurrence.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The snare was returned with the snare head retracted inside the distal end of the sheath.The handle of the device was manipulated to advance the snare head, and when the snare head was advanced outside the sheath, the snare head was misshaped.The snare head did not form a uniform duck bill.When the snare head was advanced outside the sheath, the snare wire was bent above where the duck bill is normally formed.This created two (2) bends in the snare wire.One (1) that is made to create the duck bill shape, and one (1) that was bent during use; thus creating a misshaped snare head.When the handle of the device was manipulated, difficulty was encountered while advancing and retracting the snare head.The misshaped snare head most likely contributed to difficulty advancing and retracting the snare head.A visual inspection of the very distal end of the sheath found that the sheath tubing was slightly distorted, most likely from the snare head being misshaped while it was being retracted into the sheath.The snare wire was manipulated with a pair of tweezers and formed back into a duck bill snare with one (1) bend in the distal end of the wire.The snare head smoothly advanced and retracted when manipulating the handle.When the snare head was fully retracted inside the sheath, the snare head was 26.5 mm from the distal end of the sheath, which meets specification.The sheath of the snare was disassembled from the handle to evaluate the formed snare wire.It was found that snare wire cannula that is soldered to the snare wire was not in the correct location.The position of this cannula could have contributed to the snare head becoming misshaped during use.The cannula on the complaint device was measured at 4.8 cm from the distal end of the snare wire, which does not 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.Fifty-eight (58) sealed, unused devices were returned for evaluation from eight (8) lots.The returned lots are as follows: w4041765, asdb-25-015-s, manufacture date 03/21/2018, expiration date 03/21/2021- 13 devices (lot reported) w4045389, asdb-15-015-s, manufacture date 03/27/2018, expiration date 03/27/2021- 5 devices.W3693100, asdb-25-015-s, manufacture date 03/17/2016, expiration date 03/17/2019- 1 device.W3882051, asdb-15-015-s, manufacture date 06/27/2017, expiration date 06/27/2020- 2 devices.W4018221, asdb-15-015-s, manufacture date 01/17/2018, expiration date 01/17/2021- 2 devices.W4069139, asdb-15-015-s, manufacture date 05/24/2018, expiration date 05/24/2021- 8 devices.W4098219, asdb-15-015-s, manufacture date 08/01/2018, expiration date 08/01/2021- 18 devices.W4088921, asdb-25-015-s, manufacture date 07/18/2018, expiration date 07/18/2021- 9 devices.Fifty-eight (58) sealed devices were evaluated for visual, dimensional, and functional criteria.Lot w4041765: thirteen (13) sealed devices from product lot w4041765 were returned.During a dimensional verification, all thirteen (13) devices were found to be nonconforming did not meet the manufacturing specifications for the location of the soldered cannula.A functional test was performed using a simulated test set-up, and all thirteen (13) devices failed the functional test requirement.The devices that failed had a misshaped snare head and would not fully retract back into the sheath.Lot w4045389: five (5) sealed devices from product lot w4045389 were returned.During a dimensional verification, all five (5) devices were found to be nonconforming and did not meet the manufacturing specifications for the location of the soldered cannula.A functional test was performed using a simulated test set-up, and three (3) out of the five (5) devices failed the functional test requirement.The three (3) devices that failed had a misshaped snare head and would not fully retract back into the sheath.Lot w3693100: one (1) sealed device from product lot w3693100 was returned.During a dimensional verification, the device met all manufacturing specifications.A functional test was performed using a simulated test set-up, and the sealed device failed the functional test requirement.During a visual inspection after the functional test was performed, the snare head became misshaped and would not fully retract back into the sheath.Lot w3882051: two (2) sealed devices from product lot w3882051 were returned.During a dimensional verification, both devices met all manufacturing specifications.A functional test was performed using a simulated test set-up.One (1) of the two (2) devices failed the functional test requirement.The device that failed had a misshaped snare head and would not fully retract back into the sheath.Lot w4018221: two (2) sealed devices from product lot w4018221 were returned.During a dimensional verification, both devices were found to be nonconforming and did not meet the manufacturing specifications for the location of the soldered cannula.A functional test was performed using a simulated test set-up, and one (1) of the two (2) devices failed the functional test requirement.The device that failed had a misshaped snare head and would not fully retract back into the sheath.Lot w4069139: eight (8) sealed devices from product lot w4069139 were returned.During a dimensional verification, two (2) out of the eight (8) devices were found to be nonconforming and did not meet the manufacturing specifications for the location of the soldered cannula.A functional test was performed using a simulated test set-up, and two (2) of the eight (8) devices failed the functional test requirement.Two (2) of the eight (8) devices would not fully extend; therefore, a functional test was not performed on these devices.Lot w4098219: eighteen (18) sealed devices from product lot w4098219 were returned.During a dimensional verification, eleven (11) out of eighteen (18) devices were found to be nonconforming and did not meet the manufacturing specification for the location of the soldered cannula.A functional test was performed using a simulated test set-up, and four (4) out of eighteen (18) devices failed the functional test requirement.Two (2) of the devices that failed had a misshaped snare head and would not fully retract back into the sheath.Additionally, two (2) of the devices would not fully extend, therefore a functional test was not performed on these devices.Lot w4088921: nine (9) sealed devices from product lot w4088921 were returned for evaluation.During the dimensional verification, all nine (9) devices were found to be nonconforming and did not meet manufacturing specifications for the location of the soldered cannula.During the functional test, all nine (9) devices failed the functional test requirement.During a visual inspection of the devices, each snare head of the devices were found to be misshaped.Additionally, one (1) device's sheath was kinked near the handle.After the devices had become misshaped, the devices would not retract fully back into the sheath.Investigation conclusion: the investigation determined that the originally returned device did not meet manufacturing specification.During the manufacturing process for the forming wire, the cannula was not placed at the correct location prior to being soldered to the forming wire.The operators were retrained on the manufacturing process.The returned sealed devices failed to meet the dimensional and functional requirements.The operators were retrained on the manufacturing process.A field action request was initiated.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 is included 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 colonoscopic resection of a polyp, the physician used a cook acusnare polypectomy snare.The device stuck to the tissue and was unable to complete full resection of the polyp.The device was removed.There was bleeding.Further information was received by cook product management on 30-august-2018: "[the physician] had a major malfunction during resection of a polyp with a 25 mm cook duckbill acusnare.I believe this was in the colon.This malfunction resulted in a serious adverse event - bleeding." the following was received on 17-september-2018: the bleeding was stopped with another manufacturer's hemostasis clip.A section of the device did not remain inside the patient¿s body.A hemostasis clip was used due to this occurrence.According to the initial reporter, the patient experienced bleeding 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
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7901814
• MDR Text Key: 121562071
• Report Number: 1037905-2018-00436
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002226494
• UDI-Public: (01)00827002226494(17)210321(10)W4041765
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K851958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2021
• Device Catalogue Number: ASDB-25-015-S
• Device Lot Number: W4041765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention