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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THD SPA THD DISPOSABLE STERILE AND NOT STERIE ANO-, PROCTO- RECTOSCOPES AND LIGHT-SCOPE ANOSCOPE AND ACCESSORIES

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THD SPA THD DISPOSABLE STERILE AND NOT STERIE ANO-, PROCTO- RECTOSCOPES AND LIGHT-SCOPE ANOSCOPE AND ACCESSORIES Back to Search Results
Catalog Number 800118
Device Problems Material Perforation (2205); Contamination /Decontamination Problem (2895)
Patient Problem Insufficient Information (4580)
Event Date 03/23/2020
Event Type  malfunction  
Event Description
The peel pack has perforation in it- compromised sterility. 3 each found while pulling supplies for case. Manufacturer response for light scope recto max 25cm, (brand not provided) (per site reporter). Told to discard of product and they are sending no charge replacements.
 
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Brand NameTHD DISPOSABLE STERILE AND NOT STERIE ANO-, PROCTO- RECTOSCOPES AND LIGHT-SCOPE
Type of DeviceANOSCOPE AND ACCESSORIES
Manufacturer (Section D)
THD SPA
1731 se oralabor road
ankeny IA 50021
MDR Report Key10689497
MDR Text Key211683958
Report Number10689497
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number800118
Device Lot Number042119C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/29/2020
Event Location Hospital
Date Report to Manufacturer10/16/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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