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

Catalog Number	130403
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 device has not been returned to date and no photographic evidence was provided.Therefore, the reported event cannot be verified.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 risk analysis cannot be conducted since conmed does not own the risk documents for this device.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
During incoming inspection, the distributor rejected this device, 138114a, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This will be reported as a malfunction with potential for injury upon reoccurrence.
Event or Problem Description
During incoming inspection, the distributor rejected this device,130403, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This will be reported as a malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: b5 the name of the device was corrected from 138114a to 130403.The device has not been returned to date and no photographic evidence was provided.Therefore, the reported event cannot be verified.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 risk analysis cannot be conducted since conmed does not own the risk documents for this device.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: VALUEBLUE PENCIL, PB VB STERILE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ZHEJIANG SHUYOU SURGICAL; instrument co., ltd; anji economic development zone; anji county, huzhou city 31121 0; CH 311210
• Manufacturer (Section G): ZHEJIANG SHUYOU SURGICAL; instrument co., ltd; anji economic development zone; anji county, huzhou city 31121 0; CH 311210
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 19211738
• Report Number: 1320894-2024-00114
• Device Sequence Number: 6904299
• Product Code: GEI
• UDI-Device Identifier: 06924274955962
• UDI-Public: (01)06924274955962(17)240103(10)2101002
• 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: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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: Other
• Device Expiration Date: 01/03/2024
• Device Catalogue Number: 130403
• Device Lot Number: 2101002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic