MAUDE Adverse Event Report: GYRUS ACMI, INC MOLLY FCP,3MM/33CM (5/PK); FORCEPS

Model Number 3300PK

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

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

Event Date 12/03/2014

Event Type  malfunction  

Manufacturer Narrative

The single use device was not returned to olympus for evaluation.Information in the complaint indicates the complaint occurred in 2014.From the information that has been shared with us about the incident, it appears that the device in question was reprocessed and reused multiple times.This is a single-use device and this is clearly stated on the packaging.The device should not be sterilized or cleaned for reuse.If this device is reprocessed damage to its internal components can occur and this can affect the functionality of the device including the ability to seal(coagulate) tissue.

Event Description

We were informed that during a procedure in (b)(6) 2014 the device did not coagulate.From the information that has been shared with us about the incident, it appears that the device in question was reprocessed and reused multiple times.This is a single-use device and this is clearly stated on the packaging.The device should not be sterilized or cleaned for reuse.If this device is reprocessed damage to its internal components can occur and this can affect the functionality of the device including the ability to seal(coagulate) tissue.

• Brand Name: MOLLY FCP,3MM/33CM (5/PK)
• Type of Device: FORCEPS
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: terrence sullivan ; 136 turnpike road; southborough, MA 01772 ; 508804-273
• MDR Report Key: 7283193
• MDR Text Key: 100770769
• Report Number: 3011050570-2018-00001
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PK031078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2018

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: Health Professional
• Device Model Number: 3300PK
• Device Lot Number: 470145FE
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention