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 Consequences Or Impact To Patient (2199)

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: 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.The device was sent back to the supplier for evaluation.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 product was returned to the approved supplier for evaluation and the investigation is on-going.Once additional information has been received a follow-up emdr report will be provided.

Event Description

During a colonoscopy screening, the physician used a cook captura biopsy forceps without spike.The following was provided to a cook director [non-(b)(6) speaking] in an email in (b)(6) on 05/22/2017: "please find attached an adverse event statement with a biopsy forceps.The offending dm [medical device] is available at the pui [facility] if you wish.Thank you for letting us know what you will do with this statement." the document attached to the email was also in (b)(6).The customer provided the following information on 11/02/2017, when following up with the complaint: "the snare does not come out of the endoscope." the lot number w3816721 [dbf-2.4-230-s] was provided per the customer.The following was received on 11/09/2017 per the cook sales representative: "the device involved with this complaint is not a cook device." therefore, the file was closed upon confirmation from the cook sales representative.A device matching the originally reported lot number and reference product number (rpn) was received at cook endoscopy after the file was closed.On 12/01/2017, the device was evaluated and found to be unable to close upon handle actuation.The cook sales representative reached out to the customer to confirm what the description of the event is for the returned device, and to confirm the previous discrepancies.The following was received on 12/04/2017 from the cook sales representative: "i just received an email from the pharmacist [located at the user facility].In (b)(6), the biopsy forceps did not close after use (biopsy forceps always in the patient and in gastroscope) [device was used].The cook sales representative was not originally informed of the complaint that took place in (b)(6).A translation from (b)(6) to english of the document received in may 2017 was received on 12/05/2017: "the forceps broke after removal.It was impossible to remove it from the biopsy channel of the endoscope because it remained open.[the user] changed forceps.".

Manufacturer Narrative

Investigation evaluation: 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 each attempt was 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.The device was sent back to the supplier for evaluation.The supplier provided the following evaluation: one (1) device from the reported event was returned in a zip type bag with proof of decontamination.For the returned device, the device was tested for "would not close.¿ during functional testing, with the device coiled in three (3), eight (8) inch loops, it was confirmed that the device would not operate properly when the handle was manipulated.The device would not open or close as intended.Upon further investigation and disassembly of the device tip, it was noted that the device had a butt joint that was broken at the solder connection.The reported defect of "would not close" was confirmed.The root cause for "would not close" is a broken solder connection.The device history records were reviewed.The assembly order for this lot was manufactured december 2016.Relevant defects were noted in the manufacturing records and the final quality control checklist.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 "forceps cups will open but will not close" issue experienced by the customer was confirmed and the root cause is determined to be a broken solder joint.The supplier is currently working on improvements to create a more robust soldering process to prevent solder joints from breaking.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.The instructions for use regarding product inspection states: "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." 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 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.A review of the complaint history was conducted.The likelihood of occurrence is considered rare.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
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7104936
• MDR Text Key: 95760926
• Report Number: 1037905-2017-00746
• Device Sequence Number: 1
• Product Code: FCL
• UDI-Device Identifier: 00827002315761
• UDI-Public: (01)00827002315761(17)200116(10)W3816721
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/26/2017
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2017
• 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