MAUDE Adverse Event Report: OSTA CUTTING LOOP (12/PK)

Model Number MLE-28-012

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event could not be determined at this time.

Event Description

Olympus was informed that during a therapeutic procedure, three cutting loops broke off and fell into the patient.It was reported that the surgeon retrieved all the device fragments.The intended procedure was completed with a fourth cutting loop.There was no patient injury reported.This is report 1 of 3.

Manufacturer Narrative

The user facility provided additional information which states during a transurethral resection of bladder tumor (turbt) procedure, the wire of one cutting loop broke off and fell into the patient.The surgeon immediately withdrew the loop from the patient¿s bladder.The device fragments were retrieved.The non olympus generator settings were cut 150/coag 50.The procedure was completed with a second loop.Please also reference the mfr.Numbers 2951238-2017-00380 and 2951238-2017-00381 for additional corrections.

• Brand Name: CUTTING LOOP (12/PK)
• Type of Device: CUTTING LOOP
• Manufacturer (Section D): OSTA; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6593204
• MDR Text Key: 76034558
• Report Number: 2951238-2017-00379
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MLE-28-012
• Device Catalogue Number: MLE-28-012
• Device Lot Number: 789563JF
• Other Device ID Number: UDI
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2017
• 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