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

Model Number	0100S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a lap chole, the back from the tip of the device's coating appeared sheared away.The surgeon then opened a medtronic hook to complete the procedure.The surgeon concerned to get all remnants out of patient.The surgery was delayed 7 minutes and the case was successfully completed with no patient consequences.There were fragments generated but they were easily removed without additional intervention.
Additional Manufacturer Narrative
(b)(4).Date of event: (b)(6) 2022.Photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.No lot or batch number was provided therefore a device history could not be done.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/17/2022.Photo analysis: this is an evaluation of an image sent by the account.Image: two electrodes can be seen, the insulation is cut, but it seems to still be present.Image: img_2031_(1), a closer view of two electrodes can be seen, the insulation is cut, but it seems to still be present.No conclusion could be reached as to how this issue occurred through photo analysis.Because the instrument was not returned our evaluation is limited.

• 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.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15445361
• Report Number: 1721194-2022-00084
• Device Sequence Number: 4750373
• Product Code: GEI
• UDI-Device Identifier: 10614559100677
• UDI-Public: 10614559100677
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K913281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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 Model Number: 0100S
• Device Catalogue Number: 0100S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown