MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY GOLDLINE,ROCKER,HOLS,ULTRACLN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	131307A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event of ¿insufficient heat seal¿ is confirmed.One 131307a returned unopened in original packaging.The lot number of the device 201904044 was verified.A visual inspection found the clear side of packaging and paper side was separating, causing a gap in the seal.A functional test was performed which indicated the packaging of the device had an insufficient heat seal, the seal had separated causing dye to leak into the gap.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding 165 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the ifu the user is advised that these devices should be inspected before each use.Visually examine the devices for obvious physical damage including cracked, broken or otherwise distorted plastic parts.Damage including cuts, punctures, nicks, abrasions, unusual lumps significant discoloration.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
During incoming inspection, the distributor rejected this device,131307a, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: GOLDLINE,ROCKER,HOLS,ULTRACLN
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 12370407
• Report Number: 3007305485-2021-00348
• Device Sequence Number: 17226854
• Product Code: GEI
• UDI-Device Identifier: 30653405056632
• UDI-Public: (01)30653405056632(17)240402(10)201904044
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K791137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

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: Other
• Device Expiration Date: 04/02/2024
• Device Model Number: 131307A
• Device Catalogue Number: 131307A
• Device Lot Number: 201904044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1