MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLN L-WR LAP SPLIT STEM 33CM; E-Z CLEAN WIRE L-WIRE LAP SPLIT STEM 33 CM

Catalog Number	0100S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 6/28/2019.Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Additional information: two photos were provided for review.During review of the photos, damage to the insulation was observed.The insulation appears to have been sliced with the piece of insulation sliced completely off the device.The cuts appear to be straight and clean which indicates the most likely cause of the damage is the device came in contact with a sharp instrument during the use.
Event or Problem Description
It was reported that during an ¿laparoscopic cholecystectomy procedure megadyne l hook, small black piece of insulating plastic on back of l hook came off.The piece was retrieved and removed from the patient¿s abdomen.

• Brand Name: E-Z CLN L-WR LAP SPLIT STEM 33CM
• Common Device Name: E-Z CLEAN WIRE L-WIRE LAP SPLIT STEM 33 CM
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8745469
• Report Number: 1721194-2019-00103
• Device Sequence Number: 2039090
• Product Code: GEI
• UDI-Device Identifier: 10614559100677
• UDI-Public: 10614559100677
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K913281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2019

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: 11/30/2023
• Device Catalogue Number: 0100S
• Device Lot Number: 186748
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/28/2019
• Patient Sequence Number: 1