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

Catalog Number INSC-7-230-S

Device Problems Separation Failure (2547); Failure to Fire (2610)

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Type  Injury  

Event Description

During an unspecified procedure, the physician used a cook instinct endoscopic hemoclip.It was reported that the physician tried to deploy clip but it wouldn't deploy and the jaws would not open.They were unable to get the clip to release from the catheter or release from the tissue.The nurses and doctor jiggled the catheter but the clip still wouldn't deploy.The clip eventually deployed but the patient presented for re-bleeding a few days later.An unintended section of the device did not remain inside the patient¿s body.Patient presented with rebleeding days later and required another endoscopy procedure.

Manufacturer Narrative

Pma/510(k): k212323.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 review of the device history record could not be conducted because the lot number was not provided.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 state: "to permanently deploy clip, pull handle spool toward handle thumb ring until clip detaches.Note: if separation of clip is not immediate, gently move catheter back and forth or use other endoscopic maneuvers to separate catheter from clip." the instructions for use include the following precaution: "if clip deployment device is used with endoscope in a torqued or retroflexed position, clip deployment difficulties can occur." prior to distribution, all instinct endoscopic hemoclips are subjected to a visual and functional inspection to ensure device integrity.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 ENDOSCOPIC HEMOCLIP
• 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: 15017603
• MDR Text Key: 295953564
• Report Number: 1037905-2022-00389
• Device Sequence Number: 1
• Product Code: PKL
• 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
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INSC-7-230-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 SCOPE UNKNOWN MODEL
• Patient Outcome(s): Required Intervention