MAUDE Adverse Event Report: BEAVER-VISITEC INTERNATIONAL, INC BEAVER ACCU-TEMP HIGH TEMPERATURE CAUTER, 2 INCH SHAFT WITH FINE TIP (10/BOX); THERMAL CAUTERY UNIT

Catalog Number 8445000

Device Problems Melted (1385); Nonstandard Device (1420); Component Missing (2306); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Information (3190)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

Component missing.

Event Description

Customer complaint was received alleging that two accu-temp high temperature cautery devices were found prior to use, each sealed in its tyvek-mylar pouch.One unit appeared to have evidence of a partially melted white cap and a breach in the sterile pouch.The other product packaging contained a breach in the sterile pouch only which appeared to be caused by the unit with the melted cap.The customer stated no other damage was observed.

• Brand Name: BEAVER ACCU-TEMP HIGH TEMPERATURE CAUTER, 2 INCH SHAFT WITH FINE TIP (10/BOX)
• Type of Device: THERMAL CAUTERY UNIT
• Manufacturer (Section D): BEAVER-VISITEC INTERNATIONAL, INC; 500 totten pond rd; 10 citypoint; waltham MA 02451
• Manufacturer (Section G): BEAVER-VISITEC INTERNATIONAL, INC; 500 totten pond rd; 10 citypoint; waltham MA 02451
• Manufacturer Contact: robin rowe ; 500 totten pond rd; 10 citypoint; waltham, MA 02451 ; 2698065779
• MDR Report Key: 7896738
• MDR Text Key: 121566436
• Report Number: 1211998-2018-00002
• Device Sequence Number: 1
• Product Code: HQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K771189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/15/2018

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: No Information
• Device Catalogue Number: 8445000
• Device Lot Number: 6002809
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1