ENDOPATH CURVED SCISSORS 5DCS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-27 for ENDOPATH CURVED SCISSORS 5DCS manufactured by Stryker Sustainability.

Event Text Entries

[115649478] Reprocessed laparoscopic scissors did not cut. Ethicon endo surgery, (b)(6) us.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5078678
• MDR Report Key: 7731185
• Date Received: 2018-07-27
• Date of Report: 2018-07-26
• Date of Event: 2018-07-25
• Date Added to Maude: 2018-07-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• 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: 0

• Brand Name: ENDOPATH CURVED SCISSORS
• Generic Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Product Code: NUJ
• Date Received: 2018-07-27
• Returned To Mfg: 2018-07-26
• Model Number: 5DCS
• Catalog Number: 5DCS
• Lot Number: 8697346
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: STRYKER SUSTAINABILITY
• Manufacturer Address: 1810 WEST DRAKE DR. TEMPE AZ 85283 US 85283

Device Sequence Number: 1

• Brand Name: ENDOPATH CURVED SCISSORS
• Generic Name: LAPAROSCOPIC SCISSORS
• Product Code: NUJ
• Date Received: 2018-07-27
• Returned To Mfg: 2018-07-26
• Model Number: 5DCS
• Catalog Number: 5DCS
• Lot Number: 8697346
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER SUSTAINABILITY
• Manufacturer Address: 1810 WEST DRAKE DR. TEMPE AZ 85283 US 85283

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-07-27