SUREFIT DUAL DISPERESIVE ELECTRODE 410-2000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-18 for SUREFIT DUAL DISPERESIVE ELECTRODE 410-2000 manufactured by Conmed Corp..

Event Text Entries

[52954064] Dispersive gel on dual dispersive electrode sticks to packaging materials leaving an unprotected area on the electrode. If not noted by operating room staff patient may be unprotected from proper grounding when using electrocautery. This issue has been reported to the manufacturer numerous times since (b)(6) 2016. There have been 4 different lot numbers of affected product. Only response from manufacturer has been to send replacement product. Replacement products have been the same lot number. Surefit dual electrode - used for majority of surgical cases utilizing electrocautery. Four different affected lot numbers: 201605185, 201605114, 201606224, 201605174.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5064232
• MDR Report Key: 5895845
• Date Received: 2016-08-18
• Date of Report: 2016-08-18
• Date of Event: 2016-08-15
• Date Added to Maude: 2016-08-23
• 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: OTHER HEALTH CARE PROFESSIONAL
• 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: SUREFIT DUAL DISPERESIVE ELECTRODE
• Generic Name: SUREFIT DUAL DISPERESIVE ELECTRODE
• Product Code: JOS
• Date Received: 2016-08-18
• Catalog Number: 410-2000
• Lot Number: 201605185
• Device Expiration Date: 2018-05-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CONMED CORP.
• Manufacturer Address: UTICA NY 13502 US 13502

Device Sequence Number: 2

• Brand Name: SUREFIT DUAL DISPERESIVE ELECTRODE
• Generic Name: SUREFIT DUAL DISPERESIVE ELECTRODE
• Product Code: JOS
• Date Received: 2016-08-18
• Catalog Number: 410-2000
• Lot Number: 201605114
• Device Expiration Date: 2018-05-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: CONMED CORP.
• Manufacturer Address: UTICA NY 13502 US 13502

Device Sequence Number: 3

• Brand Name: SUREFIT DUAL DISPERESIVE ELECTRODE
• Generic Name: SUREFIT DUAL DISPERESIVE ELECTRODE
• Product Code: JOS
• Date Received: 2016-08-18
• Catalog Number: 410-2000
• Lot Number: 201606224
• Device Expiration Date: 2018-05-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: CONMED CORP.
• Manufacturer Address: UTICA NY 13502 US 13502

Device Sequence Number: 4

• Brand Name: SUREFIT DUAL DISPERESIVE ELECTRODE
• Generic Name: SUREFIT DUAL DISPERESIVE ELECTRODE
• Product Code: JOS
• Date Received: 2016-08-18
• Catalog Number: 410-2000
• Lot Number: 201605174
• Device Expiration Date: 2018-05-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: CONMED CORP.
• Manufacturer Address: UTICA NY 13502 US 13502

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-08-18