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

Model Number	G58010
Medical Device Problem Codes	Material Separation (1562); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction

• 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: 50794531
• Report Number: 1037905-2026-00557
• Device Sequence Number: 10515391
• Product Code: PKL
• UDI-Device Identifier: 00827002580107
• UDI-Public: (01)00827002580107(17)280702(10)W4952990
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K212323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: W4952990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown