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

Model Number G56071

Device Problems Solder Joint Fracture (2324); Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report and determined the cups were potentially misaligned.The device was visually examined and the cups appear to be potentially misaligned.The proximal end of the spike is not placed in between the link wires.The base of the spike is sticking out on one side, instead of being contained inside the cup housing.There is a gap between the base of the cup housing and the coiled catheter sheath.The sheath is not secured over the coiled catheter and has slid back, leaving the coiled catheter exposed.The device was sent back to the supplier for further 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."the supplier provided the following: visual evaluation: the device was visually evaluated.No defects to the handle were noted.The cups appeared potentially misaligned.The proximal end of the spike is not assembled correctly between the link wires.An approximate 12 mm section of the sheath is missing leaving the coiled cable exposed.The assembly is skewed to one side and a cup tang is protruding from the housing.Functional evaluation: the device was functionally evaluated.During testing, with the device held in straight, u­ shaped, and two (2), 8" loop coiled positions, respectively, it was confirmed that the device operated properly when the handle was manipulated.The device opened and closed as designed.Misaligned cups evaluation: the device was evaluated for a "potential misalignment of the cups".Under magnification, the visible material thickness for the device was measured to be out of spec.The reported event for "misaligned cups" was confirmed.The root cause is due to uneven positioning of the link wires during the soldering process.The device history records for packaging work order (pwo) were reviewed.Pwo consisted of one assembly order (ao), manufactured june 2019.The manufacturing records and/or fqc checklist did indicate relevant defects." investigation conclusion: the supplier provided the following: the reported issue from the user that 'a sharp piece was protruding from the cups' was confirmed.The root cause was assembly error (human error) due to uneven positioning of the link wires during soldering.A capa has been issued as a corrective action.In addition, a supplier corrective action has been initiated in an effort to reduce occurrences of the link wires being soldered at the incorrect location for disposable forceps.Prior to distribution, all captura biopsy forceps with 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 included in the scope 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.

Event Description

During an endoscopic procedure, the physician used a cook captura biopsy forceps with spike.The device was reported to have a sharp piece out of the biopsy cup [spike protruding from cups].It is unknown how the procedure was completed.There was no reportable information at this time.Additional information was received when the device was evaluated [on 01/oct/2019] noting the cups were potentially misaligned.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 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
• Manufacturer (Section G): 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: 9240989
• MDR Text Key: 220574202
• Report Number: 1037905-2019-00650
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002560710
• UDI-Public: (01)00827002560710(17)220709(10)W4235440
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2022
• Device Model Number: G56071
• Device Catalogue Number: DBF-2.4-160SP-20-S
• Device Lot Number: W4235440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Date Manufacturer Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2019
• 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