5.0MM BIOZIP HSS 3910200025

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-05-01 for 5.0MM BIOZIP HSS 3910200025 manufactured by Stryker Endoscopy San Jose.

Event Text Entries

[22053655] Additional information will be provided once investigation is completed.
Patient Sequence No: 1, Text Type: N, H10

[22123601] It was reported that, "suture broke out of eye while tying knot. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2936485-2009-00038
• MDR Report Key: 1438211
• Report Source: 07
• Date Received: 2009-05-01
• Date of Report: 2009-04-03
• Date of Event: 2009-03-30
• Date Mfgr Received: 2009-04-03
• Date Added to Maude: 2010-05-21
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: NILA PATEL
• Manufacturer Street: 5900 OPTICAL COURT
• Manufacturer City: SAN JOSE CA 95138
• Manufacturer Country: US
• Manufacturer Postal: 95138
• Manufacturer Phone: 4087542000
• Manufacturer G1: STRYKER ENDOSCOPY SAN JOSE
• Manufacturer Street: 5900 OPTICAL COURT
• Manufacturer City: SAN JOSE CA 95138
• Manufacturer Country: US
• Manufacturer Postal Code: 95138
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 5.0MM BIOZIP HSS
• Generic Name: BIOZIP
• Product Code: KGS
• Date Received: 2009-05-01
• Catalog Number: 3910200025
• Lot Number: 02J0804328
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER ENDOSCOPY SAN JOSE
• Manufacturer Address: SAN JOSE CA 95138 US 95138

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-05-01