MAUDE Adverse Event Report: COVIDIEN LLC 10MM SPECIMEN RETRIEVAL BAG FROM COVIDIEN; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number REF# 173050G

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 12/26/2019

Event Type  Injury  

Event Description

Specimen retrieval bag broke that had appendix obtained during laparoscopy procedure.Specimen fell back into abdomen and needed retrieved by another bag took more time and a potential contamination cavity product endo catch gold from covidien 10mm retrieval bag ref # 173050g fda safety report id # (b)(4).

• Brand Name: 10MM SPECIMEN RETRIEVAL BAG FROM COVIDIEN
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LLC
• MDR Report Key: 9538637
• MDR Text Key: 173501557
• Report Number: MW5091949
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: REF# 173050G
• Was Device Available for Evaluation?: No
• 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): Required Intervention
• Patient Age: 48 YR