FDA Adverse Event No answer provided Summary report: N

INSTINCT PLUS CLIP

MDR report key: 13653148 · Received March 2, 2022

Report

Report Number
13653148
Event Type
No answer provided
Date Received
March 2, 2022
Date of Event
February 17, 2022
Report Date
February 21, 2022
Manufacturer
COOK INCORPORATED
Product Code
PKL
Report Source
User Facility report
Reporter Location
PA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
339063 INSTINCT PLUS CLIP HEMOSTATIC METAL CLIP FOR THE GI TRACT PKL COOK INCORPORATED G58010 W4520081

Patients

Seq Age Sex Outcome Treatment
1 14600 DA Female