MAUDE Adverse Event Report: STERILMED, INC. HARMONIC SCALPELS/SHEARS; LECTROSURGICAL, CUTTING/COAGULATION ACCESSORY, LAPAROSCOPIC/ENDOSCOPIC REPROCESS

Catalog Number	HAR36R
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The lot number provided (r94d6a) is incorrect.Follow up attempts are being made to clarify this information.A response has not yet been received.If a response is received, a 3500a supplemental report will be submitted.Since the incorrect lot number was provided, no device history record (dhr) review could be performed.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a laparoscopic cholecystectomy procedure with harmonic scalpels/shears, and in the middle of the procedure the blade broke off the device.The surgeon retrieved the broken piece and used a new device to complete the procedure.The intent of the procedure was not altered as a result of this event.The device had patient contact, however there were no patient consequences.
Additional Manufacturer Narrative
It was reported that a patient underwent a laparoscopic cholecystectomy procedure with harmonic scalpels/shears, and in the middle of the procedure the blade broke off the device.Additional information was received on february 18, 2019 that the device of this complaint was not a sterilmed reprocessed device.The device manufacturer is ethicon inc.Therefore, since this complaint does not involve a sterilmed device it is thereby not mdr reportable.True device manufacturer has been made aware of event.Manufacturer's ref.No: (b)(4).

• Brand Name: HARMONIC SCALPELS/SHEARS
• Common Device Name: LECTROSURGICAL, CUTTING/COAGULATION ACCESSORY, LAPAROSCOPIC/ENDOSCOPIC REPROCESS
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8294201
• Report Number: 2134070-2019-00119
• Device Sequence Number: 1734627
• Product Code: NUJ
• UDI-Device Identifier: 10888551045117
• UDI-Public: 10888551045117
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2019

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 Catalogue Number: HAR36R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1