GYNECOLOGICAL RESECTOSCOPE ERIS-CF25 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-10-14 for GYNECOLOGICAL RESECTOSCOPE ERIS-CF25 * manufactured by Acmi Corp..

Event Text Entries

[312212] During a hysteroscopy and polyp removal, the physician noted 2 pieces of plastic floating in the cavity. The resectoscope was removed, found the plastic end had broken off. New hysteroscope was inserted, plastic pieces were removed. After removal, cavity reinspected, no further pieces of foreign body found.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 550254
• MDR Report Key: 550254
• Date Received: 2004-10-14
• Date of Report: 2004-10-07
• Date of Event: 2004-10-05
• Report Date: 2004-10-07
• Date Reported to FDA: 2004-10-14
• Date Added to Maude: 2004-10-22
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: GYNECOLOGICAL RESECTOSCOPE
• Generic Name: RESECTOSCOPE
• Product Code: FJL
• Date Received: 2004-10-14
• Model Number: ERIS-CF25
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 539768
• Manufacturer: ACMI CORP.
• Manufacturer Address: 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US

Device Sequence Number: 2

• Brand Name: *
• Generic Name: TELESCOPE
• Product Code: FBP
• Date Received: 2004-10-14
• Model Number: M2/12 DEGREE
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 539769
• Manufacturer: ACMI CORP.
• Manufacturer Address: 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US

Device Sequence Number: 3

• Brand Name: *
• Generic Name: OBTURATOR
• Product Code: FEC
• Date Received: 2004-10-14
• Model Number: ERTO-CF25 -CFR
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 539770
• Manufacturer: ACMI CORP.
• Manufacturer Address: 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US

Device Sequence Number: 4

• Brand Name: *
• Generic Name: OUTER SHEATH
• Product Code: FED
• Date Received: 2004-10-14
• Model Number: DA 25.6
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 539771
• Manufacturer: ACMI CORP.
• Manufacturer Address: 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-10-14