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

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.

• 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 Key: 8944176
• MDR Text Key: 219183454
• Report Number: 3010452421-2019-00001
• Device Sequence Number: 1
• Product Code: GDY
• UDI-Device Identifier: 00749756158367
• UDI-Public: 00749756158367
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Number: 1-418NS
• Device Lot Number: 47481307
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/29/2019
• 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 Number: 1