MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA SERRATED JUMBO FORCEPS - SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC

Catalog Number	DBF-2.8SJ-230SP-S
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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.A photo of the lot number was provided.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 forceps is coiled may result in damage to the performance characteristics of the forceps." the instructions for use states: "using slight pressure on handle, close forceps around tissue or object.Note: it is not necessary to apply excessive pressure to cleanly excise tissue.Caution: if forceps fail to close, slowly pull cups against channel opening.Remove endoscope and forceps as a unit, then manually close cups and withdraw forceps from endoscope." prior to distribution, all cook captura serrated jumbo forceps- 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 or Problem Description
During two (2) separate colonoscopy procedures, the physician used one (1) cook captura serrated jumbo forceps- spike in each procedure.As reported to cook customer relations by the sales representative: "i am having some trouble with the jumbo captura forceps.I have had two break while we were trying to use them.It caused us to have to pull the colonoscope and forceps out at the same time.I pulled all of this lot number.[there were] two (2) different providers and two (2) different technicians [involved in the procedures].".
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.A functional test was performed on the device by testing to see if the cups will open or close.When the handle of the device was manipulated, the forceps cups will open and close as intended.On multiple attempts the forceps cups would open and close as intended.The device was then placed down a pentax ec-3830tl (3.2 mm channel) endoscope.The endoscope was placed in a curved position to simulate worst-case scenario.The handle of the device was manipulated and the cups will open and close as intended.The forceps cups were examined under magnification.During our evaluation the cups were visually evaluated and potential cup misalignment was observed.The device is being sent back to the supplier for further evaluation where the final determination of cup misalignment will be determined based on the manufacturer¿s specifications.The supplier provided the following evaluation: twelve (12) devices from the reported event were returned with proof of decontamination.The device said to be involved in the procedure, and eleven (11) sealed devices from the same lot were received.The returned device from the reported event was tested for "broke in use." during functional testing, with the device coiled in three (3), approximately eight (8) inch loops, it was confirmed that the device would operate properly when the handle was manipulated.The device opens and closes.Upon further investigation the device was inserted in to a colonoscope.In a torturous path configuration the device opened and closed as intended.The reported defect of "broke in use" could not be confirmed.Upon further visual inspection the device was inspected for misaligned cups.Under magnification, the visible material thickness was measured to be greater than the allowable dimension.The fork arms are relatively parallel.The misaligned cups were confirmed.Misalignment could have happened during use.The eleven (11) returned devices (sealed in pouches) from the same lot as the reported event were tested: sealed devices #1, 2, 5, 6, 7, 8, 9,10, 11- the returned devices from the same lot as the reported event were tested for "broke in use".During functional testing, with each of the devices coiled in three (3), approximately eight (8) inch loops, it was confirmed that the devices operated properly when the handles were manipulated.The devices open and close.Upon further investigation, the devices were individually inserted in to a colonoscope.In a torturous path configuration, the devices opened and closed as intended.The reported defect of "broke in use" could not be confirmed.Upon further visual inspection the devices were evaluated for "misaligned cups." the defect of "misaligned cups" was not confirmed.Sealed device #3 - the returned device from the same lot as the reported event was tested for "broke in use".During functional testing, with the device coiled in three (3), approximately eight (8) inch loops, it was confirmed that the device would operate properly when the handle was manipulated.The device opens and closes.Upon further investigation the device was inserted in to a colonoscope.In a torturous path configuration the device opened and closed as intended.The reported defect of "broke in use" could not be confirmed.Upon further visual inspection the device was inspected for misaligned cups.Under magnification, the visible material thickness was measured to be greater than the allowable dimension.The fork arms are relatively parallel; however these measurements indicate that the forks were not swaged tightly enough to prevent movement within the fork assembly, allowing the cups to misalign.The defect of "misaligned cups" was confirmed.Device #4 - the returned device from the same lot as the reported event was tested for "broke in use".During functional testing, with the device coiled in three (3), approximately eight (8) inch loops, it was confirmed that the device would operate properly when the handle was manipulated.The device opens and closes.Upon further investigation the device was inserted in to a colonoscope.In a torturous path configuration the device opened and closed as intended.The reported defect of "broke in use" could not be confirmed.Upon further visual inspection the device was inspected for misaligned cups.Under magnification, the visible material thickness was measured to be greater than the allowable dimension.The fork arms are relatively parallel.These measurements indicate that the forks were not swaged tightly enough to prevent movement within the fork assembly, allowing the cups to misalign.The link wire and drive wire solder joint was also visually inspected.It was observed that the link wires are twisted in the solder connection.The twisting of the link wires in the solder joint can cause the cups to misalign.The defect of "misaligned cups" was confirmed.The reported defect "broke in use" could not be confirmed.The defect "misaligned cups" was confirmed in three (3) of the twelve (12) returned devices.The device history records for the packaging work order were reviewed.The packaging work order consisted of one (1) assembly order.This assembly order was manufactured in may 2017.For the event reported in the field of "broke during use" (open/close), there were no relevant defects noted in the manufacturing and/or final quality control (fqc) records.For the inquiry of misaligned cups, there were relevant defects noted in the manufacturing and/or fqc 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 customer experienced issue of "broke during use" (unable to open or close) was not confirmed; all of the devices would open and close when the handle was manipulated.For the concern of misaligned cups, all twelve (12) devices were evaluated.The returned device (used in the field) was visually inspected under magnification.The material thickness was measured and determined to be greater than the thickness specification.The fork arms were relatively parallel.Misaligned cups were confirmed.However, it is unknown if the misalignment occurred during use in the field.Two (2) of the eleven (11) sealed devices were confirmed for misaligned cups.It was determined that an improper swage may have led to misaligned cups.All devices receive a 100% inspection final quality control (fqc) inspection for proper opening and closing as well as misaligned cups prior to product release.Awareness training will be provided to the operators.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 forceps is coiled may result in damage to the performance characteristics of the forceps." the instructions for use states: "using slight pressure on handle, close forceps around tissue or object.Note: it is not necessary to apply excessive pressure to cleanly excise tissue.Caution: if forceps fail to close, slowly pull cups against channel opening.Remove endoscope and forceps as a unit, then manually close cups and withdraw forceps from endoscope." prior to distribution, all cook captura serrated jumbo forceps- 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 or Problem Description
The following was initially reported to the fda on 07/21/2017: "during two (2) separate colonoscopy procedures, the physician used one (1) cook captura serrated jumbo forceps- spike in each procedure.As reported to cook customer relations by the sales representative: i am having some trouble with the jumbo captura forceps.I have had two (2) break while we were trying to use them.It caused us to have to pull the colonoscope and forceps out at the same time.I pulled all of this lot number.[there were] two (2) different providers and two (2) different technicians [involved in the procedures]." on 07/28/2017, the device was received for evaluation.It was not found to be "broken", but was found to be potentially misaligned.

• Brand Name: CAPTURA SERRATED JUMBO FORCEPS - SPIKE
• Common Device Name: FCL, FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 6733585
• Report Number: 1037905-2017-00494
• Device Sequence Number: 822172
• Product Code: FCL
• UDI-Device Identifier: 00827002530423
• UDI-Public: (01)00827002530423(17)200517(10)W3866636
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DBF-2.8SJ-230SP-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1