MAUDE Adverse Event Report: Wilson-Cook Medical Inc INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE; Hemostatic Clip

Model Number	G58010
Medical Device Problem Codes	Separation Failure (2547); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic clipping procedure, the physician used a cook instinct plus endoscopic clipping device.It was reported that while the clip was being inserted through the scope, the staff member was holding the red part of the handle, the clip could not be deployed.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.
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A photo of the device coiled in the pouch was provided, the lot number of the label matches that in the report.The device history record for the lot number said to be involved was reviewed.Nonconformances that could potentially be related to the complaint were contained in the associated dhr.The nonconformance documentation supports the affected device(s) were dispositioned appropriately prior to release of this lot.There is no evidence nonconforming product was released for distribution.In an effort to heighten awareness of the potential connection of the customers report to the current manufacturing processes production personnel were notified.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use states, "note: if separation of the clip is not immediate, gently move the catheter back and forth or use other endoscopic maneuvers to separate the catheter from the clip." prior to distribution, all instinct plus endoscopic clipping devices 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: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.

• Brand Name: INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
• Common Device Name: Hemostatic Clip
• Manufacturer (Section D): Wilson-Cook Medical Inc; 4900 bethania station rd; winston salem NC 27105
• Manufacturer (Section G): Wilson-Cook Medical Inc; 4900 bethania station rd; winston salem NC 27105
• Manufacturer Contact: sabrina o¿brien ; 4900 bethania station rd; winston salem, NC 27105 ; +1(336)744-0157
• MDR Report Key: 50883693
• Report Number: 1037905-2026-00583
• Device Sequence Number: 13441215
• Product Code: PKL
• UDI-Device Identifier: 00827002580107
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K212323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G58010
• Device Catalogue Number: INSC-P-7-230-S
• Device Lot Number: W5029884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Olympus Scope, unknown model.
• Patient Sex: Unknown