MAUDE Adverse Event Report: ESPINER MEDICAL LTD. ESPINER TISSUE RETRIEVAL SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number EMP50ECO-R

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2017

Event Type  malfunction  

Event Description

Eco-sac tissue retrieval loop pulled off of sac when surgeon was attempting to pull sac with specimen out of abdomen.

• Brand Name: ESPINER TISSUE RETRIEVAL SYSTEM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ESPINER MEDICAL LTD.; 190 industrial rd.; wrentham MA 02093
• MDR Report Key: 6597846
• MDR Text Key: 76189381
• Report Number: 6597846
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2022
• Device Model Number: EMP50ECO-R
• Device Catalogue Number: EMP50ECO-R
• Device Lot Number: 1585
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15 YR