MAUDE Adverse Event Report: COOK ENDOSCOPY INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE; PKL, LIGATOR, HEMORRHOIDAL

Model Number G58010

Device Problems Separation Failure (2547); Failure to Fire (2610); Difficult or Delayed Separation (4044)

Patient Problem Laceration(s) (1946)

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

(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.A corrective action has been initiated to reduce occurrences of deployment difficulty for instinct plus clips.Prior to distribution, all instinct plus endoscopic clipping device 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: a corrective action has been initiated in an effort to reduce occurrences of this nature.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 a colonoscopy procedure, the physician used a cook instinct plus endoscopic clipping device.The staff had difficulty deploying the clip.They were able to finally deploy it, but it took extra effort and time to do so.As a result, in the process of trying to deploy the clip, the pressure caused a small mucosal tear in the descending colon.The information provided states that no additional procedures were required as a result of the tear.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 experienced a mucosal tear.No further intervention was required.

Manufacturer Narrative

A correction was made to the annex a code.

• Brand Name: INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
• Type of Device: PKL, LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 12187562
• MDR Text Key: 262159802
• Report Number: 1037905-2021-00319
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00827002580107
• UDI-Public: (01)00827002580107(17)220331(10)W4455540
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: G58010
• Device Catalogue Number: INSC-P-7-230-S
• Device Lot Number: W4455540
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS COLONOSCOPE, MODEL UNKNOWN; OLYMPUS COLONOSCOPE, MODEL UNKNOWN.