MAUDE Adverse Event Report: UNIMAX MEDICAL SYSTEMS, INC. MINI ENDO POCKET BAG 3X4; SPECIMEN BAGS

Catalog Number SB534

Device Problems Break (1069); Defective Component (2292)

Patient Problem Injury (2348)

Event Date 10/11/2017

Event Type  Injury  

Manufacturer Narrative

The manufacturer unimax medical systems, inc.Is responsible for performing evaluation, investigation and any remedial actions related to this reported device issue per agreement with (b)(4).

Event Description

This is a voluntary distributor report.The user facility reported that during a laparoscopic bilateral salpingo-oophorectomy the sb534 mini endo pocket broke while trying to retrieve a specimen.It was reported that there was no tension on the bag when it broke.A second sb534 bag was used to attempt to complete the procedure but it was noticed to be defective.The second bag was removed and the incision was widened to remove the ovary manually.The procedure was completed with a 5-minute surgical delay and no patient injury was reported.Upon additional information gathered from the reporter, the patient did not need to stay in the hospital for any additional length of time due to this incident.Due to the incision needing to be widened to complete the procedure, this incident is raised based on a patient injury.

• Brand Name: MINI ENDO POCKET BAG 3X4
• Type of Device: SPECIMEN BAGS
• Manufacturer (Section D): UNIMAX MEDICAL SYSTEMS, INC.; 8f-2, no. 127; lane 235, pao chiao road; hsin tien city, taipei, ; TW
• MDR Report Key: 6999383
• MDR Text Key: 90976142
• Report Number: 3007216334-2017-00238
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: SB534
• Device Lot Number: 8251704310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2017
• Distributor Facility Aware Date: 10/23/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 88