MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT

Model Number G50697

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

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 an esophagogastroduodenoscopy (egd) and colonoscopy procedure, the physician used a cook capture pro¿ biopsy forceps with spike.The [physician] described that during the egd, the advancement of the forceps did not feel right, but they were able to obtain eight (8) samples.During the colonoscopy, the cook sales representative was called into the case to observe the device, and it was noted that the serrated portion of the forceps cups were not lined up [misalignment].The cook representative advised them to switch to a new device.The procedure was completed successfully with the new device.It is unknown by the user and cook representative if the forceps cups were misaligned prior to the procedure/advancement down the endoscope.A section of the device did not remain inside the patient¿s body.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

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During a functional test, the handle was manipulated and the forceps cups opened and closed fully.There was no resistance felt in the handle when actuating the cups.However, when the cups were closed, the teeth did not mesh completely on one side.The cups appear to be slightly misaligned.During the evaluation of the device, the forceps were advanced down an olympus 2.8 mm channel endoscope.When the handle was manipulated, the forceps cups would open and close as intended.The device was sent back to the supplier for further evaluation.The supplier provided the following investigation: "the forceps were visually evaluated.There was evidence of damage.One of the cups was bent/twisted causing the teeth to misalign.A functional evaluation is not possible due to the condition of the device.The cups opened and closed properly but they were misaligned.The teeth did not mesh properly.The customer complaint of "cup misaligned issue" was confirmed; the cups were misaligned.We are unable to determine how or when this damaged occurred, but the most likely cause of this failure is that one cup experienced an unusual force causing the cup to bend/ twist.The physician relayed information that during the egd procedure, the advancement of the forceps did not "feel right", but they were able to obtain eight (8) samples.It is standard practice to actuate the device prior to use.This type of damage is visible, and therefore, it is unlikely that this damage occurred prior to use.The assignable cause of the forceps misalignment appeared to be an unusual force.The device history records were reviewed.This lot was manufactured in april 2019.There were relevant defects 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 user's complaint that the serrated portion of cups were not lined up was confirmed.The assignable cause was not conclusive but likely a result of an unusual force.All devices receive a 100% inspection prior to release and shipment.Prior to distribution, all captura pro¿ biopsy forceps are subjected to a visual inspection and functional testing to ensure device integrity.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 and this represents an isolated occurrence.The likelihood of occurrence is considered remote.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 an esophagogastroduodenoscopy (egd) and colonoscopy procedure, the physician used a cook captura pro¿ biopsy forceps with spike.The [physician] described that during the egd, the advancement of the forceps did not feel right, but they were able to obtain eight (8) samples.During the colonoscopy, the cook sales representative was called into the case to observe the device, and it was noted that the serrated portion of the forceps cups were not lined up [misalignment].The cook representative advised them to switch to a new device.The procedure was completed successfully with the new device.It is unknown by the user and cook representative if the forceps cups were misaligned prior to the procedure/advancement down the endoscope.A section of the device did not remain inside the patient¿s body.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.

• Brand Name: CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE
• Type of Device: PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8827800
• MDR Text Key: 152399941
• Report Number: 1037905-2019-00412
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002506978
• UDI-Public: (01)00827002506978(17)220419(10)W4205915
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2022
• Device Model Number: G50697
• Device Catalogue Number: BF-2.4SL-230SP-40
• Device Lot Number: W4205915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS PEDIATRIC ENDOSCOPE, UNKNOWN MODEL