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

Catalog Number DBF-2.4-230-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

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.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

In preparation for an endoscopic procedure, the physician selected two (2) cook captura biopsy forceps without spike.The forceps jaws are not functioning (opening or closing).

Manufacturer Narrative

Investigation evaluation: returned device 1 - our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the returned device, the device was functionally tested.When the handle of the device was manipulated the forceps cups will open, but they will not close.Several attempts were made to close the forceps cups, but they were unsuccessful.The device was then placed down an olympus gif-q20 (2.8 mm channel) endoscope.The endoscope was put in a torturous path.When the handle was manipulated the device would open, but the cups would not close.Returned device 2 - our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the returned device, the device was functionally tested.When the handle of the device was manipulated the forceps cups will open, but they will not close.Several attempts were made to close the forceps cups, but they were unsuccessful.The device was then placed down an olympus gif-q20 (2.8 mm channel) endoscope.The endoscope was put in a torturous path.When the handle was manipulated the device would open, but the cups would not close.Both devices was sent to the supplier for further evaluation.The supplier provided the following evaluation: two (2) devices from the reported event were returned in a zip type bag with proof of decontamination.Device 1: for the returned device, the device was tested for "would not open or close." during functional testing, with the device initially straightened and then coiled in three (3), eight inch loops, it was confirmed that the device did not operate properly when the handle was manipulated.The device opened but did not close as intended.Upon further investigation and disassembly of the device tip, it was noted that the device solder connection was broken.The reported defect of "would not open" was not confirmed; however the reported defect of "would not close" was confirmed.Device 2: for the returned device, the device was tested for "would not open or close." during functional testing, with the device initially straightened and then coiled in three (3), eight inch loops, it was confirmed that the device did not operate properly when the handle was manipulated.The device opened but did not close as intended.Upon further investigation and disassembly of the device tip, it was noted that the device solder connection was broken.The reported defect of "would not open" was not confirmed; however the reported defect of "would not close" was 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: the supplier provided the following information: the "forceps cups will open but will not close" issue experienced by the customer was confirmed and the root cause was determined to be a broken solder joint.On 01/02/2018, the improved soldering process was implemented in manufacturing.In addition, a corrective action has been initiated to reduce occurrences of cups open and close difficulties for disposable forceps.The product said to be involved is included in the scope of the corrective actions.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.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.H3 other text : investigation evaluation: returned device 1 - our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the returned device, the device was functionally tested.When the handle of the device was manipulated the forceps cups will open, but they will not close.Several attempts were made to close the forceps cups, but they were unsuccessful.The device was then placed down an olympus gif-q20 (2.8 mm channel) endoscope.The endoscope was put in a torturous path.When the handle was manipulated the device would open, but the cups would not close.Returned device 2 - our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the returned device, the device was functionally tested.When the handle of the device was manipulated the forceps cups will open, but they will not close.Several attempts were made to close the forceps cups, but they were unsuccessful.The device was then placed down an olympus gif-q20 (2.8 mm channel) endoscope.The endoscope was put in a torturous path.When the handle was manipulated the device would open, but the cups would not close.Both devices was sent to the supplier for further evaluation.The supplier provided the following evaluation: two (2) devices from the reported event were returned in a zip type bag with proof of decontamination.Device 1: for the returned device, the device was tested for "would not open or close." during functional testing, with the device initially straightened and then coiled in three (3), eight inch loops, it was confirmed that the device did not operate properly when the handle was manipulated.The device opened but did not close as intended.Upon further investigation and disassembly of the device tip, it was noted that the device solder connection was broken.The reported defect of "would not open" was not confirmed; however the reported defect of "would not close" was confirmed.Device 2: for the returned device, the device was tested for "would not open or close." during functional testing, with the device initially straightened and then coiled in three (3), eight inch loops, it was confirmed that the device did not operate properly when the handle was manipulated.The device opened but did not close as intended.Upon further investigation and disassembly of the device tip, it was noted that the device solder connection was broken.The reported defect of "would not open" was not confirmed; however the reported defect of "would not close" was 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: the supplier provided the following information: the "forceps cups will open but will not close" issue experienced by the customer was confirmed and the root cause was determined to be a broken solder joint.On 01/02/2018, the improved soldering process was implemented in manufacturing.In addition, a corrective action has been initiated to reduce occurrences of cups open and close difficulties for disposable forceps.The product said to be involved is included in the scope of the corrective actions.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.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.

• 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: 7303143
• MDR Text Key: 101579025
• Report Number: 1037905-2018-00076
• Device Sequence Number: 1
• Product Code: FCL
• UDI-Device Identifier: 00827002315761
• UDI-Public: (01)00827002315761(17)200201(10)W3825123
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DBF-2.4-230-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1