MAUDE Adverse Event Report: BEAVER-VISITEC INTERNATIONAL INC BEAVER-VISITEC INTERNATIONAL, INC; ACCU-TEMP® CAUTERY, LOW TEMP, 0.5" FINE TIP

Model Number	8443000
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Unclear Information (4052)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Per uf report (b)(4).Beaver-visitec international holdings, inc.(bvi) accu-temp low temperature and high temperature cautery devices appear nearly identical in their packaging which can lead to confusion when selecting items for use for procedures.The handle portion of both items is white.In the package, these items are also covered with a white cap to protect the cautery tip.The handle does have small font on each item that state high or low temp, but this found is also nearly identical in color and size on the two items.It isn't until these items are on the surgical field for use when there is a notable difference; the high temp cautery has a blue tip below the loop tip whereas the low temp device has a white or light gray tip below the loop.Bvi accu-temp low temperature cautery; 1/2 in shaft with fine tip; ref # 8441000; lot # 6061506.Bvi accu-temp high temperature cautery; 1/2 in shaft with loop tip; ref # 8443000; lot # 6053065.A patient was having a procedure of medial and lateral rectus exploration /recession for exotropia.A high-temp cautery tool was used when low temp cautery tool was intended.This may have contributed to a small scleral laceration.
Additional Manufacturer Narrative
The bvi quality assurance department has followed its internal procedure to investigate the complaint.The investigation included a review of current process controls and the historical device register (dhr).All manufacturing operations were recorded; all signatures and dates were present.No product was returned however the customer has provided a photograph for evaluation.The photograph was evaluated, and it is understood that confusion may have arisen due to the similar physical appearance between the high and low temperature cautery tools.However, in the course of performed investigation, bvi has clarify that each tool is clearly labeled with its specific type on the box and on the product itself.It has been therefore confirmed that the labels of both products are correctly marked to avoid confusion.According to the analysis performed, the root cause was not identified due to the photograph demonstrated that device are correctly identified.Complaint database was reviewed and complaint was considered as single and isolated.No further actions are required at this point.
Event or Problem Description
The customer clarified within the report made directly to fda (# (b)(4)) that the notification is unrelated to the patient, it is in reference to the nearly identical packaging of devices that can easily lead to confusion when selecting the device.

• Brand Name: BEAVER-VISITEC INTERNATIONAL, INC
• Common Device Name: ACCU-TEMP® CAUTERY, LOW TEMP, 0.5" FINE TIP
• Manufacturer (Section D): BEAVER-VISITEC INTERNATIONAL INC; 500 totten pond rd; 10 citypoint; waltham MA 02451 1916
• Manufacturer (Section G): BEAVER-VISITEC MEXICO; valle de los cedros; 1520; ciudad juarez, chihuahua 32575 ; MX 32575
• Manufacturer Contact: agnieszka drzewiecka ; 500 totten pond rd; 10 citypoint; waltham, MA 02451-1916 ; 8669068080
• MDR Report Key: 20092173
• Report Number: 1211998-2024-00015
• Device Sequence Number: 7736265
• Product Code: HQP
• UDI-Device Identifier: 00886158010241
• UDI-Public: (01)00886158010241
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K771189
• 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,Followup
• Report Date (Section B): 10/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 06/23/2026
• Device Model Number: 8443000
• Device Catalogue Number: 8443000
• Device Lot Number: 6053065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 84 KG