MAUDE Adverse Event Report: STERILMED, INC. HARMONIC SCALPELS/SHEARS; ELECTROSURG, CUT & COAG ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED

Model Number HAR36R

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a laparoscopic gastric bypass procedure with a reprocessed harmonic scalpels/shears and the tip broke off.The tip was believed to retrieved and discarded.A new device was used to complete the procedure with no patient harm.Attempt has been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

The device has not yet been returned for analysis.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 sterilmed, inc., or its employees that the report constitutes an admission that the product, sterilmed, inc., 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.Manufacturer's ref.(b)(4).

Manufacturer Narrative

Additional information was received on 21-jul-2022.The surgeon stated that there were no signs of the device having difficulty before the blade broke.The device was being used in the case as it always is.The surgeon does take bites of soft tissue after it has been stapled and could have had a staple in the jaws during activation.This is something that he always does.The blade broke and it was retrieved without issue.The product was discarded by mistake, therefore it can not be returned.Since the device has been reported as discarded, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: HARMONIC SCALPELS/SHEARS
• Type of Device: ELECTROSURG, CUT & COAG ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer (Section G): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15070196
• MDR Text Key: 304713781
• Report Number: 2134070-2022-00014
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 10888551045117
• UDI-Public: 10888551045117
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HAR36R
• Device Catalogue Number: HAR36R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1