MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO SHEARS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	176643
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the use of the monopolar on cholecystectomy, the plastic covering the blades burns.Another scissor was used.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.A visual inspection of the returned products noted that the end of the plastic shafts had been burnt.Jaws of the devices were inspected under a microscope, where no abnormalities or damage was found.A functional evaluation found that: jaws of devices opened and closed without difficulty.Devices rotated without difficulty.Dissecting jaws cut test media without difficulty.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted that the end of the plastic shaft had been burnt.Jaws of the device were inspected under a microscope, where no abnormalities or damage was found.A functional evaluation found that: jaws of device opened and closed without difficulty.Device rotated without difficulty.Dissecting jaws cut test media without difficulty.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO SHEARS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 9329626
• Report Number: 2647580-2019-05644
• Device Sequence Number: 16798460
• Product Code: GEI
• UDI-Device Identifier: 10884523000733
• UDI-Public: 10884523000733
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K951589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 176643
• Device Catalogue Number: 176643
• Device Lot Number: P9F1060PY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 12/18/2019; 01/23/2020
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 12/27/2019; 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1