MAUDE Adverse Event Report: GYRUS ACMI INC. BIPOLAR LAPAROSCOPIC LOOP

Model Number BL0533

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2014

Event Type  malfunction  

Event Description

The user facility reported that the black insulated coating of the device cracked and a chip fell into the patient.The chip was retrieved from the patient.No patient injury was reported.Olympus followed up with the user facility via telephone to obtain more detailed information about the reported event but with no results.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined.If additional information is received at a later time this report will be supplemented.

• Brand Name: BIPOLAR LAPAROSCOPIC LOOP
• Type of Device: BIPOLAR LAPAROSCOPIC LOOP
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01772 210
• Manufacturer (Section G): GYRUS ACMI; 136 turnpike road; southborough MA 01772 210
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4077575
• MDR Text Key: 21733822
• Report Number: 2951238-2014-00333
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL0533
• Device Catalogue Number: BL0533
• Device Lot Number: U1310125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other