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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A. LAP SPONGE; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

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ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A. LAP SPONGE; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE Back to Search Results
Model Number 1-418NS
Device Problems Material Separation (1562); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2019
Event Type  malfunction  
Manufacturer Narrative
An internal complaint (b)(4) was received indicating that an x-ray detectable element of a laparotomy sponge (part 1-418ns, lot 47481307) was exposed and came out with minimal tension.The defective sample was not available for return.However, the reporting customer provided a photo that confirmed the reported issue.The investigation is ongoing at this time.This report will be updated when new and critical information becomes available.
 
Event Description
The x-ray detectable piece is exposed on the side of the sponge.The longer strip came out without minimal tension.
 
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Brand Name
LAP SPONGE
Type of Device
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Manufacturer (Section D)
ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A.
km 20.5 carretera a villa cana
zona 3 finca morancito
villa canales, 01065
GT  01065
Manufacturer (Section G)
ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A.
km 20.5 carretera a villa cana
zona 3 finca morancito
villa canales, 01065
GT   01065
Manufacturer Contact
sarah bennett
200 debusk lane
powell, TN 37849
8653626112
MDR Report Key8944176
MDR Text Key219183454
Report Number3010452421-2019-00001
Device Sequence Number1
Product Code GDY
UDI-Device Identifier00749756158367
UDI-Public00749756158367
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1-418NS
Device Lot Number47481307
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/01/2019
Initial Date FDA Received08/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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