MAUDE Adverse Event Report: SC003 SC-FORT MILL MAYAGUEZ MC UROLOGY PACK (PPPRD)503; GENERAL SURGERY TRAY (KIT)

Model Number	SOT30PPPR1
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based in the information provided for this product number (29455) with lot number 3249mr2, this product was manufactured in november 20th, 2019.The device history records for the lot were reviewed.There were no issues documented concerning the defect reported by customer.The actual sample involved in the reported incident was not returned for evaluation.No additional information, pictures or videos were received.The product is manufactured according with the current product specification.Current manufacturing process was evaluated.A fish-bone diagram was used to determine possible root causes.Results are as follow: man: operators are properly trained and certified in their tasks.Machine: all parameters were within the validation process windows.Calibration and maintenance programs are properly performed.Material: the materials for assembly product 29455 met the current specification requirements.Process / method: instructions for assembling product 29455 were reviewed, all of them (specifications.Standard production method and visual aid) were properly documented and posted.Process failure mode effect analysis (pfmea) # 23 rev.13 was also reviewed, and no change was required.No opportunities were found that could generate this condition during the manufacturing process.Inspection / measurement: device history record (dhr) and data documentation of cusum (cumulative sum) inspection of the number 3249mr2 were reviewed.There were no comments for linting issue related.Environment: no environment factors associated with this defect.Manufacturing process in control and no deviation found.Process failure mode effect analysis was reviewed.No opportunities were found that could generate this condition during the manufacturing process.Weak adhesive not detected at manufacturing process and in inspection documents.No change in the materials used to assembly the product 29455.Assembly process at plant was reviewed for code 29455 reported with weak in product issue.An ishikawa diagram was used to determine any deviation during the assembly process.Current process met the specification required.All elements were evaluated (man, machine, material, method, measurement and environmental) are according to the established manufacturing procedure.No deviation was found during the evaluation performed.The product is manufactured according with the product specification.Actual defective sample is necessary to determine the root cause analysis.Since no sample of the reported defect is available and defect could not be replicate in our process, we determine, no action will be taken.The root cause could not be identified.The production team was notified of a weak issue was found on the product 29455.Effective date: 10/01/2020.
Event or Problem Description
Based on information from the customer the drape was used even though it reportedly did not stick on patient during urology procedure.Allegedly there was less than a 20-minute delay in the procedure where the patient was under anesthesia.Per the information gathered from the customer there was no injury or adverse effect to the patient.

• Brand Name: MAYAGUEZ MC UROLOGY PACK (PPPRD)503
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): SC003 SC-FORT MILL; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 10689194
• Report Number: 1423537-2020-00542
• Device Sequence Number: 11625723
• Product Code: LRO
• UDI-Device Identifier: 10888439774511
• UDI-Public: 10888439774511
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2020

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
• Operator of Device: Health Professional
• Device Model Number: SOT30PPPR1
• Device Catalogue Number: SOT30PPPR1
• Device Lot Number: 565820
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 10/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other