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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADEPT-MED INTERNATIONAL, INC. GLASSMAN VISCERA RETAINER; VISCERA RETAINER, FISH ®
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ADEPT-MED INTERNATIONAL, INC. GLASSMAN VISCERA RETAINER; VISCERA RETAINER, FISH ® Back to Search Results
Model Number 3204
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Information (3190)
Date of Event 11/16/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Reporting physician states : he has utilized a glassman viscera retainer, fish at least 500 times in the past without incident.Not available for evaluation.
 
Event or Problem Description
Received a telephone call from reporting party on 12/08/2016 who relayed the following information : on (b)(6) 2016, j.Doe had a surgical procedure that required a large abdominal incision.A glassman viscera retainer, size medium, item# 3204 was used in the closure.J.Doe did well after surgery.On (b)(6) 2016, j.Doe was taken for an x-ray, unrelated to the original surgery and a glassman viscera retainer radiopaque strip was visible in the x-ray and identified as a retained foreign object.J.Doe was taken to surgery on that same day, 2 skin sutures and 1 facial suture from the original surgery were removed and the glassman viscera retainer was removed without incident.Reporting party states the 2nd surgery was completed in 15 minutes.
 
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Brand Name
GLASSMAN VISCERA RETAINER
Common Device Name
VISCERA RETAINER, FISH ®
Manufacturer (Section D)
ADEPT-MED INTERNATIONAL, INC.
665 pleasant valley rd
diamond springs CA 95619
MDR Report Key6236863
Report Number2918699-2017-70001
Device Sequence Number929338
Product Code GCZ
Combination Product (Y/N)N
Initial Reporter StateDC
Initial Reporter CountryUS
PMA/510(K) Number
K802806
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number3204
Device Catalogue Number3204
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/08/2016
Initial Report FDA Received Date01/10/2017
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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