MAUDE Adverse Event Report: ZHEJIANG SHUYOU SURGICAL VALUEBLUE PENCIL, PB VB STERILE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	IIIA-D006-SG040
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
Investigation of the customer's complaint of an insufficient heat seal leading to a breach in sterility has confirmed the reported issue.Conmed received two 130403 returned unopened in original packaging.The lot number of the device ¿ 2008080 was verified.A visual inspection found gaps in the seal caused by the packaging lifting.A functional inspection was then performed, and the devices were dye leak tested per policy.The dye leak testing indicated the packaging had an insufficient heat seal on both returned devices.An evaluation by the supplier on reserved samples of the same batch found no issues with the seal of the package.A two-year lot history review shows this is the only complaint for this lot number and failure mode.The device history record provided from the supplier found no abnormalities that would contribute to this issue.A risk analysis cannot be conducted for this device since conmed does not own the risk documents for this device.Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.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, catalog # 130403 lot 2008080, for a possible breach of sterility due to an insufficient heatseal.There was no contact with any patient as this was found during incoming inspection in (b)(6).The completion of the device evaluation confirmed an insufficient heatseal; therefore, this complaint meets the criteria for a reportable event.Due to the breach in sterility, this report is being raised as a malfunction with potential for injury upon reoccurrence.

• Brand Name: VALUEBLUE PENCIL, PB VB STERILE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ZHEJIANG SHUYOU SURGICAL; anji economic development zone; industrial park huzhou zhejian ; CH
• MDR Report Key: 12386798
• Report Number: 1320894-2021-00325
• Device Sequence Number: 11920790
• Product Code: GEI
• UDI-Device Identifier: 06924274955955
• UDI-Public: (01)06924274955955(17)230817(10)2008080
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040780
• 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): 08/30/2021

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: No Information
• Device Expiration Date: 08/17/2023
• Device Model Number: IIIA-D006-SG040
• Device Catalogue Number: 130403
• Device Lot Number: 2008080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 08/30/2021
• Patient Sequence Number: 1