MAUDE Adverse Event Report: COOK INCORPORATED INSTINCT PLUS CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number G58010

Device Problem Component Missing (2306)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/17/2022

Event Type  No Answer Provided  

Event Description

Patient presented to gastrointestinal (gi) lab for push enteroscope and colonoscopy.Push enterscope performed, large gi bleed noted.Devices opened with emergence, clip opened handed off to doctor (md) who placed into scope.Once down the scope channel, md asked tech to open clip device, it was noted that there was no clip at the end of the device.It is unknown if clip was deployed accidentally or this was a manufacturing defect.2 more clips handed off emergently and successfully placed and as well as hemospray used and argon plasma coagulation (apc) probe.Patient was ordered blood urgently, and given.Patient was also intubated urgently.End count of devices not able to be reconciled as the clip was missing.Reported to assistant nurse manager (anm), who debriefed with staff and md immediately.All gi device packaging searched.Patient was searched along with linens and pads for missing clip, was not found.2 scopes used both were boroscoped, device again not found, both scopes sent out for inspection after appropriate reprocessing.Other clip packages searched all clips on stock were noted to have the distal clip attached.Manufacturer made aware by calling device rep, who will file report.Rep stated no concerns of same nature reported recently.In-service scheduled for staff for following week regarding inspection of devices prior to hand off to md.Case discussed at huddle in morning as well as device inspection prior to hand off.Patient had been ordered chest x-ray (cxr), after discussion with md, abdominal x-ray (abdxr) ordered in attempt to locate said clip.Abdxr repeated following day as well in attempt to locate clip and identify previous clips seen initially.Per md "no patient harm" or adverse affect to patient.Report given to nurse on ip unit by anm.Device kept for inspection.Or peri-op director made aware and debriefed.

• Brand Name: INSTINCT PLUS CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 13653148
• MDR Text Key: 286491957
• Report Number: 13653148
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2022

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 Model Number: G58010
• Device Catalogue Number: INSC-P-7-230-S
• Device Lot Number: W4520081
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14600 DA
• Patient Sex: Female