MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH; HF RESECTION ELECTRODE, LOOP

Lot Number 12046P03L001

Device Problem Component Missing (2306)

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

Event Date 11/19/2014

Event Type  Other  

Event Description

End of electrosurgical loop was noted to be missing.Unknown if loop was defective.

• Type of Device: HF RESECTION ELECTRODE, LOOP
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH
• MDR Report Key: 4296414
• MDR Text Key: 5085651
• Report Number: MW5039339
• Device Sequence Number: 1
• Product Code: FAS
• 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: 11/25/2014

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?: No
• Device Operator: Health Professional
• Device Lot Number: 12046P03L001
• Other Device ID Number: 0104042761036689
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR