MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA BIOPSY FORCEPS WITHOUT SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC

Catalog Number DBF-2.4-160-20-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

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.The instructions for use state the following in regards to product inspection: "beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Become familiar with the amount of handle movement required to operate the cups.If any irregularities are noted, do not use.Note: exercising the handle while the forcep is coiled may result in damage to the performance characteristics of the forceps." prior to distribution, all captura biopsy forceps without spike are subjected to a visual inspection and functional test to ensure proper workability.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 biopsy procedure, the physician chose a cook captura biopsy forceps without spike.The valve [handle] that opens and closes [the cups] has broken off, so it will not work properly anymore.When using it, the cup snaps.The mechanism of open and close fails.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A visual inspection was performed on the returned device and the forceps cups were closed and bent at an angle.The link wires were severely mangled causing the forceps cups to be in the closed position at an angle.The forceps cups themselves were not bent.When the handle of the device was manipulated, the cups would respond to the handle manipulation movements, however the forceps cups would not open.Due to the damaged link wires, the device was not advanced through an endoscope.The device was sent to the supplier for further evaluation.The supplier provided the following evaluation: one device from the reported event was returned in a zip type bag with proof of decontamination.During a functional evaluation for the returned device, the device was evaluated for "would not open or close." during functional testing, with the device coiled in two (2), eight (8) inch loops, it was confirmed that the device did not operate properly when the handle was manipulated.The device does not open or close as intended.For the returned device, the link wires and cup assembly were also evaluated.The cup assembly was found to be bent at a ninety (90) degree angle, stemming from the end of the sheath.The device link wires were also severely bent and damaged.The device was then disassembled to evaluate the solder connection.The connection was found to be intact.Inadequate functionality was due to the bent link wires.The root cause of the bent link wires is unknown.The device history records were reviewed and found to be manufactured in july 2017.Relevant defects were noted in the manufacturing and/or final quality control checklist records.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 supplier provided the following: the reported issue "mechanism of open and close fails" was evaluated and the findings confirmed that the device does not open or close as intended.Bent link wires were the cause of the inadequate functionality of the device.The assignable cause of the bent link wires is unknown.All devices receive a 100% inspection prior to release and shipment.The instructions for use includes the following to ensure proper use of the device: "beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Become familiar with the amount of handle movement required to operate the cups.If any irregularities are noted, do not use.Note: exercising the handle while the forcep is coiled may result in damage to the performance characteristics of the forceps." "forceps cups must remain closed during introduction into, advancement through, and removal from endoscope.If cups are open, damage to forceps and/or endoscope may occur."gentle pressure must be used when operating handle of forceps.Excessive pressure will result in rigidity of the forceps, which may damage forceps and/or endoscope." "with cups closed, insert forceps into accessory channel.Note: keep end of forceps extending from accessory channel straight at all times.Allowing forceps to hang from accessory channel may cause damage to forceps." "maintain gentle handle pressure to keep cups closed and gently withdraw forceps from site." prior to distribution, all captura biopsy forceps without spike are subjected to a visual inspection and functional test to ensure proper workability.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.H3 other text : investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A visual inspection was performed on the returned device and the forceps cups were closed and bent at an angle.The link wires were severely mangled causing the forceps cups to be in the closed position at an angle.The forceps cups themselves were not bent.When the handle of the device was manipulated, the cups would respond to the handle manipulation movements, however the forceps cups would not open.Due to the damaged link wires, the device was not advanced through an endoscope.The device was sent to the supplier for further evaluation.The supplier provided the following evaluation: one device from the reported event was returned in a zip type bag with proof of decontamination.During a functional evaluation for the returned device, the device was evaluated for "would not open or close." during functional testing, with the device coiled in two (2), eight (8) inch loops, it was confirmed that the device did not operate properly when the handle was manipulated.The device does not open or close as intended.For the returned device, the link wires and cup assembly were also evaluated.The cup assembly was found to be bent at a ninety (90) degree angle, stemming from the end of the sheath.The device link wires were also severely bent and damaged.The device was then disassembled to evaluate the solder connection.The connection was found to be intact.Inadequate functionality was due to the bent link wires.The root cause of the bent link wires is unknown.The device history records were reviewed and found to be manufactured in july 2017.Relevant defects were noted in the manufacturing and/or final quality control checklist records.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 supplier provided the following: the reported issue "mechanism of open and close fails" was evaluated and the findings confirmed that the device does not open or close as intended.Bent link wires were the cause of the inadequate functionality of the device.The assignable cause of the bent link wires is unknown.All devices receive a 100% inspection prior to release and shipment.The instructions for use includes the following to ensure proper use of the device: "beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Become familiar with the amount of handle movement required to operate the cups.If any irregularities are noted, do not use.Note: exercising the handle while the forcep is coiled may result in damage to the performance characteristics of the forceps." "forceps cups must remain closed during introduction into, advancement through, and removal from endoscope.If cups are open, damage to forceps and/or endoscope may occur."gentle pressure must be used when operating handle of forceps.Excessive pressure will result in rigidity of the forceps, which may damage forceps and/or endoscope." "with cups closed, insert forceps into accessory channel.Note: keep end of forceps extending from accessory channel straight at all times.Allowing forceps to hang from accessory channel may cause damage to forceps." "maintain gentle handle pressure to keep cups closed and gently withdraw forceps from site." prior to distribution, all captura biopsy forceps without spike are subjected to a visual inspection and functional test to ensure proper workability.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: CAPTURA BIOPSY FORCEPS WITHOUT SPIKE
• Type of Device: FCL, FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7433239
• MDR Text Key: 106016054
• Report Number: 1037905-2018-00154
• Device Sequence Number: 1
• Product Code: FCL
• UDI-Device Identifier: 00827002560611
• UDI-Public: (01)00827002560611(17)200807(10)W3902604
• Combination Product (y/n): N
• 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: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DBF-2.4-160-20-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/23/2018
• Device Age: 7 MO
• Event Location: Home
• Date Manufacturer Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOSCOPE, UNKNOWN MODEL