MAUDE Adverse Event Report: GYRUS ACMI INC. SLIMLINE -SEMI RIGID FORCEPS; GRASPER FORCEPS

Model Number GYA-5

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the reported phenomenon could not be determined at this time.If additional information or if device is received at a later date, this report will be supplemented.The instruction for use states, always operate the forceps lightly- excessive force on the finger grip (either pushing or pulling) can cause deterioration and breakage.

Event Description

Olympus was informed that during an unspecified procedure, the tip of the device broke off and fell inside the patient while the physician was trying to remove an essure coil that did not deploy properly.There was minor bleeding that occurred as a result of removing the coil.The device fragment was not found during straining of the patient's cavity after the procedure.In addition, the patient required a longer stay and was admitted for a 24 hour observation and will be requiring additional procedure to remove the coil.It is unknown at this time if the broken piece was retrieved from the patient.No further information was provided.

• Brand Name: SLIMLINE -SEMI RIGID FORCEPS
• Type of Device: GRASPER FORCEPS
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01772 2104
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355161
• MDR Report Key: 5251882
• MDR Text Key: 32200768
• Report Number: 2951238-2015-00560
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 11/25/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: GYA-5
• Device Catalogue Number: GYA-5
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization