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

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).

• Brand Name: ESPINER TISSUE RETRIEVAL SYSTEM ECO-SAC
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ESPINER / FANNIN UK LTD. / GLOBAL MEDICAL PARTNERS; louisville CO 80027
• MDR Report Key: 9279236
• MDR Text Key: 165227926
• Report Number: MW5090862
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: EMP60ECO-R
• Device Lot Number: 2846
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 YR
• Patient Weight: 32