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

Model Number G31585

Device Problems Failure to Align (2522); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: non-healthcare professional.The product was returned for evaluation on 26-feb-2020 and the investigation is on-going.A follow-up emdr will be submitted.

Event Description

During a biopsy procedure, the physician use a cook captura biopsy forceps with spike.The disposable biopsy forceps (dbf) cups would not close.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.

Event Description

During a biopsy procedure, the physician use a cook captura biopsy forceps with spike.The disposable biopsy forceps (dbf) cups would not close.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 confirmed the complaint as described by the user.The device was visually examined, and one of the cups is severely bent at the cup tang.It seems as if the cup experienced a severe force, which caused it to bend inwardly and skew the cups when they are in the closed position.The link wires attached to the bent cup, are slightly bent into the cup housing.However the link wires are able to actuate as they should.During a functional test, the handle was manipulated, and the cups would open as intended but could not fully close since the cup is bent and hindering the cups from coming together.There was no resistance felt in the handle when actuating the cups.The covering over the coiled catheter has moved back and the coiled catheter is exposed near the base of the cup housing.Due to the condition the device was returned in, the forcep was not function tested in the scope.No other anomalies were detected with the device.The device was sent back to the supplier for a full evaluation.The supplier provided the following: visual evaluation: the cups are misaligned, one cup is extremely bent/twisted.Functional test: a functional evaluation was not performed.One cup is extremely bent causing the cups to be misaligned.The device will not function properly with this condition.The condition of this device is consistent with excessive force.The device history records were reviewed.The manufacturing records and/or fqc checklist did include relevant defects.There were 14 rejects for misaligned cups in assembly order and 20 rejects in another assembly order.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 complaint was confirmed but the root cause was not determined.Therefore, a corrective action is not warranted.The condition of the device is consistent with excessive force.All devices receive a 100% inspection prior to shipment.This device would not have passed final inspection.Prior to distribution, all captura biopsy forceps with spike 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.

• Brand Name: CAPTURA 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: 9770784
• MDR Text Key: 224676168
• Report Number: 1037905-2020-00111
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002315853
• UDI-Public: (01)00827002315853(17)221113(10)W4286090
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2022
• Device Model Number: G31585
• Device Catalogue Number: DBF-2.4-230SP-S
• Device Lot Number: W4286090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE, UNKNOWN MAKE AND MODEL