MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE; PKL, LIGATOR, HEMORRHOIDAL

Model Number G58010

Device Problems Material Separation (1562); Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k): k212323.The product was returned for evaluation and the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with product evaluation information.

Event Description

During an unspecified procedure, the physician prepared to use an instinct plus endoscopic clipping device.It was reported that when the package was opened and as the clip catheter was being unravelled, it was discovered that the external jaws of the clip were either missing and/or fell off, prior to the catheter being inserted into the endoscope.A picture included depicted the clip at distal end, outer arms fell off just after removal from packet or was never present, difficult to categorically state which.As it was discovered prior to patient contact, 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

Pma/510(k): k212323 investigation evaluation: the product said to be involved was returned in a biohazard bag that contained the box and open pouch from the lot number provided in the report.The label matches the product returned.The pictures provided show the labeling of the product and the distal end of the device; the clip jaws appear to be missing from the device.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned in the closed position.Both of the clip jaws were missing, the nitinol strips are still present.The clip opens and closes during handle manipulation.The device was not function tested in the scope due to the condition of the returned device.A visual examination of the distal end under magnification did not identify a root cause.The clip jaws were not present or returned with the device.The rest of the distal end components had no anomalies or damage.The device was returned to the supplier and the following was provided, "the external jaws of the clip and the housing are missing.They were not with the returned device.A laboratory evaluation could not be performed because the product said to be involved was returned with the jaws and housing missing.We can only confirm that the jaws and housing are not attached to the device tip.Each instinct plus device is functionally tested to ensure that the tip opens and closes as intended.This device passed the open and close testing, therefore, it can be determined that the jaws and housing were present prior to it leaving the manufacturing facility." the device history records were reviewed.This lot was manufactured december 2021.There were no relevant defects mentioned in the device history record review 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: our evaluation of the returned device determined the clip jaws were missing.A definitive cause for the reported observation could not be determined, the clip jaws were detached and not returned with the device.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The supplier provided the following: the complaint was confirmed.The root cause could not be determined due to the condition of the returned device.The customer issued the complaint as a heightened awareness.A review of the device record did not reveal any nonconformities associated with the user's complaint.A laboratory evaluation could not be performed due to the condition of the returned device." prior to distribution, all instinct plus endoscopic clipping device 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.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.

• Brand Name: INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
• Type of Device: PKL, LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 14877486
• MDR Text Key: 303278166
• Report Number: 1037905-2022-00356
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002580107
• UDI-Public: (01)00827002580107(17)241208(10)W4544835
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G58010
• Device Catalogue Number: INSC-P-7-230-S
• Device Lot Number: W4544835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2021
• 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
• Treatment: OLYMPUS GASTROSCOPE MODEL CF-HQ1901