MAUDE Adverse Event Report: COOK ENDOSCOPY INSTINCT ENDOSCOPIC HEMOCLIP; PKL, LIGATOR, HEMORRHOIDAL

Catalog Number INSC-7-230-S

Device Problem Separation Failure (2547)

Patient Problems Hemostasis (1895); Perforation (2001); Tissue Damage (2104)

Event Date 06/05/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: additional cook instinct endoscopic hemoclips.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 conclusions: 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: "precautions: if clip deployment device is used with endoscope in a torqued or retroflexed position, clip deployment difficulties can occur." 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." 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: 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.

Event Description

During an upper endoscopy procedure, the physician used a cook instinct endoscopic hemoclip.The physician observed bleeding occurring in the duodenum.The physician asked for a clip; the clip was passed through the endoscope and properly placed on bleeding site.Upon attempting to deploy the clip, the clip would not detach from the catheter.Endoscope position was lost and endoscope retracted into the stomach with the clip still attached to the bleeding site.It was observed that the bleeding site had received a rather large defect and possible perforation.A few clips were then placed on the entire site and the patient went for x-ray.An x-ray determined a perforation had occurred.The patient was observed for 2-3 days and no further procedures were needed.

• Brand Name: INSTINCT ENDOSCOPIC HEMOCLIP
• Type of Device: PKL, LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 5768867
• MDR Text Key: 48739353
• Report Number: 1037905-2016-00195
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002183438
• UDI-Public: (01)00827002183438(17)180921(10)W3626910
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/10/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: INSC-7-230-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/05/2016
• Device Age: 9 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/10/2016
• Initial Date FDA Received: 07/05/2016
• Date Device Manufactured: 09/21/2015
• 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 ENDOSCOPE (UNKNOWN MODEL)
• Patient Outcome(s): Required Intervention