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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ESPINER / FANNIN UK LTD. / GLOBAL MEDICAL PARTNERS ESPINER TISSUE RETRIEVAL SYSTEM ECO-SAC LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

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ESPINER / FANNIN UK LTD. / GLOBAL MEDICAL PARTNERS ESPINER TISSUE RETRIEVAL SYSTEM ECO-SAC LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Model Number EMP60ECO-R
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/20/2019
Event Type  Malfunction  
Event Description

Pt underwent a laparoscopic appendectomy. During procedure, the tip of product broke off into the pt. Tip was retrieved. No pt harm. Fda safety report id# (b)(4).

 
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Brand NameESPINER TISSUE RETRIEVAL SYSTEM ECO-SAC
Type of DeviceLAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
ESPINER / FANNIN UK LTD. / GLOBAL MEDICAL PARTNERS
louisville CO 80027
MDR Report Key9279236
MDR Text Key165227926
Report NumberMW5090862
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 10/31/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberEMP60ECO-R
Device LOT Number2846
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/04/2019 Patient Sequence Number: 1
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