FIXATION RING CLAMP 244001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-07-18 for FIXATION RING CLAMP 244001 manufactured by Rusch, Inc./pilling Weck.

Event Text Entries

[121567] Ring clamp snapped while using on pt. Surgery was slowed by problem. No injury to pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2429473-1998-00042
• MDR Report Key: 177997
• Report Source: 05
• Date Received: 1998-07-18
• Date of Report: 1998-07-17
• Date of Event: 1998-07-10
• Date Mfgr Received: 1998-07-14
• Date Added to Maude: 1998-07-22
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FIXATION RING CLAMP
• Generic Name: NO SCALPEL VASECTOMY INSTRUMENT
• Product Code: KOA
• Date Received: 1998-07-18
• Model Number: NA
• Catalog Number: 244001
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 173081
• Manufacturer: RUSCH, INC./PILLING WECK
• Manufacturer Address: 240 DELAWARE AVE FT. WASHINGTON PA 19034 US
• Baseline Brand Name: VASECTOMY SCALPEL
• Baseline Generic Name: VASECTOMY INSTRUMENT
• Baseline Model No: NA
• Baseline Catalog No: 244001
• Baseline ID: NA
• Baseline Device Family: ANESTHESIA
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K922971
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-07-18