MAUDE Adverse Event Report: GYRUS ACMI BERKELEY SAFETOUCH TISSUE TRAP

Device Problems Crack (1135); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2016

Event Type  malfunction  

Event Description

Sealing caps that are a part of this kit do not fit snugly, they are as we are told designed to sit on top the canister until suction is applied.This design allows the caps to fall off the unit if moved or shifted.The kit comes with one cap and if it falls to the floor another entire kit must be opened.If attempts to secure the cap to the canister is applied the cap cracks thus losing sufficient suction to perform the procedure.The design of the cap attachment to the canisters should be evaluated for a better and safer design for efficiency, cost effectiveness as well as proper use of the equipment.Reason for use: uterine dilatations and curettages.

• Brand Name: BERKELEY SAFETOUCH TISSUE TRAP
• Type of Device: BERKELEY SAFETOUCH TISSUE TRAP
• Manufacturer (Section D): GYRUS ACMI
• MDR Report Key: 5784862
• MDR Text Key: 49426112
• Report Number: MW5063330
• Device Sequence Number: 2
• Product Code: HHK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: 003853-902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1