MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC (COOK ENDOSCOPY) PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL; TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	G22757
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a feeding tube placement, the physician used a cook peg 24 percutaneous endoscopic gastrostomy set - pull.It was reported that using the knife included in the kit, a small incision was made, and then the abdomen was punctured with the enclosed needle.However, the needle did not penetrate well, and the sheath on the needle surface was pushed back.Per the photo provided the white sheath on the trocar needle is kinked/accordioned.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 performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photo provided the white sheath on the trocar needle is kinked/accordioned.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements and photo describing the event.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: 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 photo provided shows the white sheath on the trocar needle was kinked and accordioned on the needle.The ifu states: "visually inspect with particular attention to kinks, bends, and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." prior to distribution, all peg 24 percutaneous endoscopic gastrostomy set - pull 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: PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL
• Common Device Name: TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): WILSON-COOK MEDICAL INC (COOK ENDOSCOPY); 4900 bethania station rd; winston salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC (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: 22080480
• Report Number: 1037905-2025-00411
• Device Sequence Number: 15553021
• Product Code: KNT
• UDI-Device Identifier: 00827002227576
• UDI-Public: (01)00827002227576(17)271008(10)W4877139
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K920703
• Number of Events Summarized: 1
• Summary Report (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): 05/23/2025

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: G22757
• Device Catalogue Number: PEG-24-PULL-I-S
• Device Lot Number: W4877139
• 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: 04/28/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS GIF-H290
• Patient Sex: Unknown