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

Catalog Number 130403

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 341366159
• Report Number: 1320894-2024-00114
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 06924274955962
• UDI-Public: (01)06924274955962(17)240103(10)2101002
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Expiration Date: 01/03/2024
• Device Catalogue Number: 130403
• Device Lot Number: 2101002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic