MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC INSTINCT ENDOSCOPIC HEMOCLIP; HEMOSTATIC CLIP

Model Number	G18343
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - phone number: (b)(4).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.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 system preparation section of the instructions for use includes the following: "uncoil device.Verify smooth handle operation and clip action.Open clip by gently moving handle spool distally (away from handle thumb ring).Once clip is fully open, do not continue advancing handle spool as clip may prematurely detach from catheter.Close clip by moving handle spool proximally until clip is fully closed.Caution: do not continue to pull handle spool beyond tactile resistance as this may prematurely deploy clip." the instructions for use also states: "with clip closed and without holding handle spool, advance device in small increments into accessory channel of gastroscope or colonoscope.Caution: holding handle spool during clip advancement may prematurely deploy clip." failure to follow the instructions above can result in damage to the device which may lead to premature clip deployment.Prior to distribution, all instinct endoscopic hemoclips 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.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
During a bleeding case, the physician used a cook instinct endoscopic hemoclip.It was reported that the clip was initially deployed while attempting to open despite no action being taken to trigger its deployment.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.
Event or Problem Description
This follow up emdr is being sent to cancel the initial emdr sent on this event.See h11 for more details.
Additional Manufacturer Narrative
This correction follow up report is being submitted to cancel the initial report submitted relating to this event.The initial report stated that the clip was initially deployed while attempting to open despite no action being taken to trigger its deployment.Cws interpreted this event to be the clip prematurely deploying in the unknown position.Additional information was received on 08 mar 2025 stating that the clip was closed when it deployed.This has not historically caused or contributed to a serious injury or death so this incident no longer meets the reporting criteria of an fda mdr report.

• Brand Name: INSTINCT ENDOSCOPIC HEMOCLIP
• 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 (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: 21514543
• Report Number: 1037905-2025-00176
• Device Sequence Number: 7974436
• Product Code: PKL
• UDI-Device Identifier: 00827002183438
• UDI-Public: (01)00827002183438(17)250906(10)W4634071
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K132809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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 Expiration Date: 09/06/2025
• Device Model Number: G18343
• Device Catalogue Number: INSC-7-230-S
• Device Lot Number: W4634071
• 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: 02/08/2025
• Supplement Date Received by Manufacturer: 03/08/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE, UNKNOWN MAKE AND MODEL
• Patient Sex: Unknown