ACMI RIGID CYSTOSCOPE E-117-S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-04 for ACMI RIGID CYSTOSCOPE E-117-S manufactured by Unk.

MAUDE Entry Details

• Report Number: MW5089596
• MDR Report Key: 8966016
• Date Received: 2019-09-04
• Date of Report: 2019-09-03
• Date of Event: 2019-08-19
• Date Added to Maude: 2019-09-05
• Event Key: 0
• Report Source Code: Voluntary 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: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: ACMI RIGID CYSTOSCOPE
• Generic Name: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID
• Product Code: FAJ
• Date Received: 2019-09-04
• Model Number: E-117-S
• Catalog Number: E-117-S
• Lot Number: NONE
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Device Sequence Number: 2

• Brand Name: ACMI RIGID CYSTOSCOPE
• Generic Name: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID
• Product Code: FAJ
• Date Received: 2019-09-04
• Model Number: E-121-S
• Catalog Number: E-121-S
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Device Sequence Number: 3

• Brand Name: ACMI RIGID CYSTOSCOPE
• Generic Name: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID
• Product Code: FAJ
• Date Received: 2019-09-04
• Model Number: E-123-S
• Catalog Number: E-123-S
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Device Sequence Number: 4

• Brand Name: ACMI RIGID CYSTOSCOPE
• Generic Name: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID
• Product Code: FAJ
• Date Received: 2019-09-04
• Catalog Number: E-125-S
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-09-04