MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number FS-OMNI-ACRO-35-205

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/16/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: erbe electrosurgical generator.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 broken cutting wire can occur if the tip of the device is over flexed.The instructions for use caution the user: "do not over flex or bow tip beyond 90 degrees, as this may damage or cause cutting wire to break." cutting wire breakage can also occur if the cutting wire makes contact with the endoscope when electrosurgical current is applied to perform the sphincterotomy.The instructions for use caution the user: "when applying current, ensure cutting wire is completely out of endoscope." the instructions for use caution the user: ¿contact of cutting wire with endoscope may cause grounding, which can result in patient injury, operator injury, a broken cutting wire and/or damage to endoscope." if the sphincterotome is used with excessive electrosurgical current settings provided by the electrosurgical unit, this can contribute to cutting wire breakage.The instructions for use direct the user: ¿before using this device, follow recommendations provided by electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode." cutting wire breakage can occur if the elevator of the endoscope is in the closed or up position when advancing or retracting the sphincterotome.The instructions for use caution the user: "elevator should remain open/down when advancing or retracting sphincterotome." this activity will aid in device preservation.Prior to distribution, all fusion pre-loaded with acrobat wire guide sphincterotomes are subjected to a visual inspection and functional test to ensure device integrity.The functional test includes bowing the sphincterotome to ensure the distal end responds to handle manipulation.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 sphincterotomy, the physician used a cook fusion omni pre-loaded with acrobat wire guide sphincterotome.The distal end of the cutting wire snapped and approximately 1 cm was left in the patient' duodenum.The physician was unable to grasp it [the broken piece].The patient has been scanned and the piece could not be located.The patient was going to have a computed tomography (ct) scan.After several attempts to acquire additional information, it is unknown at this time if the patient will [naturally] pass the wire piece or if she will require surgery to remove the broken piece.A section of the device remained inside the patient¿s body.An attempt was made to retrieve the piece, but the physician was unsuccessful.The patient required a ct scan due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Several attempts were made to acquire additional information on if the patient required surgery, however it is currently unknown.

Manufacturer Narrative

This report is being filed to update the description of event and patient outcome.Concomitant medical products: erbe electrosurgical generator.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 broken cutting wire can occur if the tip of the device is over flexed.The instructions for use caution the user: "do not over flex or bow tip beyond 90 degrees, as this may damage or cause cutting wire to break." cutting wire breakage can also occur if the cutting wire makes contact with the endoscope when electrosurgical current is applied to perform the sphincterotomy.The instructions for use caution the user: "when applying current, ensure cutting wire is completely out of endoscope." the instructions for use caution the user: ¿contact of cutting wire with endoscope may cause grounding, which can result in patient injury, operator injury, a broken cutting wire and/or damage to endoscope." if the sphincterotome is used with excessive electrosurgical current settings provided by the electrosurgical unit, this can contribute to cutting wire breakage.The instructions for use direct the user: ¿before using this device, follow recommendations provided by electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode." cutting wire breakage can occur if the elevator of the endoscope is in the closed or up position when advancing or retracting the sphincterotome.The instructions for use caution the user: "elevator should remain open/down when advancing or retracting sphincterotome." this activity will aid in device preservation.Prior to distribution, all fusion pre-loaded with acrobat wire guide sphincterotomes are subjected to a visual inspection and functional test to ensure device integrity.The functional test includes bowing the sphincterotome to ensure the distal end responds to handle manipulation.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

The following was reported on 10-august-2018: "during a sphincterotomy, the physician used a cook fusion omni pre-loaded with acrobat wire guide sphincterotome.The distal end of the cutting wire snapped and approximately 1 cm was left in the patient' duodenum.The physician was unable to grasp it [the broken piece].The patient has been scanned and the piece could not be located.The patient was going to have a computed tomography (ct) scan.After several attempts to acquire additional information, it is unknown at this time if the patient will [naturally] pass the wire piece or if she will require surgery to remove the broken piece." clarification was received on 20-august-2018 regarding patient outcome.The consultant radiographer anticipated the wire passed naturally because the wire was no longer visible on scan.The patient did not require additional surgery to remove the piece of wire.The patient was discharged home and was well after the event.The detached portion of the device remained in the patient's body and passed naturally.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 Description

The following was reported on 10-august-2018: "during a sphincterotomy, the physician used a cook fusion omni pre-loaded with acrobat wire guide sphincterotome.The distal end of the cutting wire snapped and approximately 1 cm was left in the patient' duodenum.The physician was unable to grasp it [the broken piece].The patient has been scanned and the piece could not be located.The patient was going to have a computed tomography (ct) scan.After several attempts to acquire additional information, it is unknown at this time if the patient will [naturally] pass the wire piece or if she will require surgery to remove the broken piece." clarification was received on 20-august-2018 regarding patient outcome.The consultant radiographer anticipated the wire passed naturally because the wire was no longer visible on scan.The patient did not require additional surgery to remove the piece of wire.The patient was discharged home and was well after the event.The detached portion of the device remained in the patient's body and passed naturally.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

Concomitant medical products: erbe electrosurgical generator.Investigation evaluation: our laboratory evaluation of the returned device said to be involved confirmed the report.A visual examination of the distal end of the returned device showed that the cutting wire had separated from the catheter at the distal end.The anchor measuring 5 mm had detached and was not included in the return.The cannula at the proximal end of the cutting wire had moved proximally within the catheter.The cutting wire shows evidence of cautery application.The catheter shows no kinks/bends.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.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 the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The distal end of the device was cut by the user.This may have been in an attempt to prevent damage to the endoscope during removal of the device.A broken cutting wire can occur if the tip of the device is over flexed.The instructions for use caution the user: "do not over flex or bow tip beyond 90 degrees, as this may damage or cause cutting wire to break." cutting wire breakage can also occur if the cutting wire makes contact with the endoscope when electrosurgical current is applied to perform the sphincterotomy.The instructions for use caution the user: "when applying current, ensure cutting wire is completely out of endoscope." the instructions for use caution the user: ¿contact of cutting wire with endoscope may cause grounding, which can result in patient injury, operator injury, a broken cutting wire and/or damage to endoscope." if the sphincterotome is used with excessive electrosurgical current settings provided by the electrosurgical unit, this can contribute to cutting wire breakage.The instructions for use direct the user: ¿before using this device, follow recommendations provided by electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode." cutting wire breakage can occur if the elevator of the endoscope is in the closed or up position when advancing or retracting the sphincterotome.The instructions for use caution the user: "elevator should remain open/down when advancing or retracting sphincterotome." this activity will aid in device preservation.Prior to distribution, all fusion® pre-loaded with acrobat wire guides are subjected to a visual inspection and functional test to ensure device integrity.The functional test includes bowing the sphincterotome to ensure the distal end responds to handle manipulation.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.

• Brand Name: FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE
• 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: 7772097
• MDR Text Key: 116726851
• Report Number: 1037905-2018-00351
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 10827002346014
• UDI-Public: (01)10827002346014(17)210504(10)W4063560
• Combination Product (y/n): N
• PMA/PMN Number: K052051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2021
• Device Catalogue Number: FS-OMNI-ACRO-35-205
• Device Lot Number: W4063560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Date Manufacturer Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FUJINON 500 SERIES DUODENOSCOPE; FUJINON 500 SERIES DUODENOSCOPE
• Patient Outcome(s): Required Intervention