MAUDE Adverse Event Report: UNIMAX MEDICAL SYSTEMS, INC. ENDO POUCH W MEMORY WIRE 3X6; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number SB836

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/31/2020

Event Type  Injury  

Manufacturer Narrative

This report is being filed as a voluntary distributor report.The manufacturer, unimax medical system, inc., is responsible for performing the evaluation, investigation and any remedial actions related to this reported device issue.

Event Description

This is a voluntary distributor report.The customer reported that the device, sb836, was being used during a trans-vaginal hysterectomy when "the surgeon cut the organ inside the bag to extract these easily.Then mistakenly he cut the bag and part of the bag might remain in the patient body." further assessment information has been requested; however, the reporter has stated that no further information is known at this time.This report is being raised on the basis of injury due to suspicion of a fragment being left in the patient.

• Brand Name: ENDO POUCH W MEMORY WIRE 3X6
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): UNIMAX MEDICAL SYSTEMS, INC.; 8f-2 no. 127; lane 235, pao chioa road; hsin tien, taipai ; TW
• MDR Report Key: 9948751
• MDR Text Key: 187304674
• Report Number: 3007216334-2020-00170
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SB836
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2020
• Distributor Facility Aware Date: 03/31/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other