MAUDE Adverse Event Report: U.S. SURGITECH INC SURGYCUT; J-HOOK ELECTRODE

Model Number	790-104-535
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While using j hook in surgery, it was noticed that it was leaving blue residue inside the abdomen.
Additional Manufacturer Narrative
The used samples are returned to us by the user facility.The samples have tissues and debris including blood on it which makes it difficult to appropriately view the coating.As j-hook ( (b)(6) ) are sold for last two years and there had been no issue in the past and this is the only particular lot from which the complaints are received.An investigation has been started to find out the root cause and corrective actions to forestall such issue.In the meanwhile, it is decided to start removing the j-hook ( (b)(6) ) lot no.20231020 from the uer facility.As these devices with the same lot no.Were sold to only one facility, therefore, all devices of j-hook ( (b)(6) ) lot no.20231020 are being take back and company is blocking the sales of j-hook ( (b)(6) ) sales until the corrective actions are taken.Apparently it seems to be charring effect due to high voltage use.The instructions for use also states "using coated electrodes at high power settings may cause damage to the coating.If the coating is damaged, discard the electrode".To mitigate such issue in future, our contract manufacturer is replacing the dip coating method of tips with spray coating as a corrective action so that the coating layer is more uniformly deposited on all the tip surfaces and by chance if used at higher voltages by user, peel off can be prevented.As of 08/15/2024, all (b)(4) units of unused products out of (b)(4) units sold to the user facility are received backed by the company, whereas the remaining were used by the user facility and there is no product remaining in the user facility that can cause any further malfunctioning issue.

• Brand Name: SURGYCUT
• Common Device Name: J-HOOK ELECTRODE
• Manufacturer (Section D): U.S. SURGITECH INC; 551 kimberly drive; carol stream; chicago IL 60188
• Manufacturer (Section G): HANGZHOU TONGLU SHIKONGHOU MEDICAL INSTRUMENTS CO.; 100 sangyuan raod, tonglu; hangzhou; tonglu, zhejiang 31150 0; CH 311500
• Manufacturer Contact: hammad yousaf ; 551 kimberly drive; carol stream; chicago, IL 60188 ; 8009704877
• MDR Report Key: 20055950
• Report Number: 3004777218-2024-00002
• Device Sequence Number: 7977541
• Product Code: GEI
• UDI-Device Identifier: 00810014631103
• UDI-Public: 00810014631103
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K911316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

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: 790-104-535
• Device Catalogue Number: 790-104-535
• Device Lot Number: 20231020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Hispanic