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

Model Number HAR36R

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2020

Event Type  malfunction  

Manufacturer Narrative

The product analysis lab received the device for evaluation.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent a laparoscopic appendectomy with reprocessed harmonic scalpels/shears and the harmonic teflon pad fell off into patient during the procedure.The pad was carefully removed by the physician.No further intervention was necessary.There was no patient consequence.

Manufacturer Narrative

It was reported that a patient underwent a laparoscopic appendectomy with reprocessed harmonic scalpels/shears and the harmonic teflon pad fell off into patient during the procedure.Three photographs were received.Photograph 1 shows the backside of an ultrasonic scalpel¿s handle, including the connection port for a handpiece.It is not determined from the photograph that this is a reprocessed device.The handle appears whole and intact.The seams appear close.The device appears to have blood stains on the handle.Nothing in this photograph appears to relate to the reported issue as it doesn¿t show the distal tip of the device, jaws, or pad.Photograph 2 shows the bottom-side, proximal end of the device¿s handle.It is not determined from the photograph that this is a reprocessed device.The handle appears whole and intact.The seams appear close.The device appears to have blood stains on the handle.Nothing in this photograph appears to relate to the reported issue as it doesn¿t show the distal tip of the device, jaws, or pad.Photograph 3 shows a section of the device shaft and the distal tip including the jaws.It is not determined from the photograph that this is a reprocessed device.The tip appears to be held at more than arm¿s length distance in the photo.It also appears to be held at an angle that shows the bottom-side of the jaw that holds the tissue pad.The image in this area is blurry.The opposing side¿s metal rod appears intact, but its condition cannot be determined.The opposing, tissue pad-side appears discolored, but there also appears to be the presence of the tissue pad at the hinge area of the jaw, but the image is blurry, and the condition cannot be determined.It is unclear how much of the tissue pad is still attached to the jaw, if it¿s whole, partial, or melted.Resolution of the handle appears whole and intact.The seams appear close.The device appears to have blood stains on the handle.Nothing in this photograph appears to relate to the reported issue as it doesn¿t show the distal tip of the device, jaws, or pad.No conclusion can be made about the physical appearance of the tissue pad from the photograph.As the conditioned cannot be verified the analysis is not confirmed.The device was returned in a sealed plastic biohazard bag, with none of the other original packaging, such as the original tray the device was shipped in.The returned device was received with observed biological contaminants on the handle, shaft and tip of the device, eschar on the metal rod and a burnt, melted tissue pad.The tissue pad does not appear whole.The top section of the pad, with ridges, is either vaporized or detached.The base of the tissue pad is still seated in the jaw's grooves.A detachment supports the report of the "pad fell off." the observations are indicative of continuous device activation with or without tissue between the blade and the pad and patient contact.No detached piece(s) was returned with the device.Per additional information received, the piece was removed from the patient's body "by doctor, very carefully during the procedure." it was also noted "no further measures needed." per the failure modes and effects analysis (fmea) for harmonic ace with att, possible causes for the "pad missing or fragments fall off" is "damage to the distal tip," "activation of device without tissue between the blade and the pad," and "physician misuse." the presence of biological contaminants, eschar on the metal rod and melting on the pad is also evidence that the device was functioning to a level that it would be recognized by the gen11 generator and had passed the setup screen in order for the max & min buttons to be able to fire.The reported issue is confirmed.However, as the observed evidence is indicative of the device being actuated within the operative field, and the failure is reported to have occurred intra-op, no conclusion as to the cause for the reported issue is determined.The device history record for lot 2063328 was reviewed, and the device was shown to have passed all visual and functional criteria prior to being distributed to the customer.A manufacturing record evaluation was conducted and there were no identified nonconformances.Manufacturer's ref.(b)(4).

• Brand Name: HARMONIC SCALPELS/SHEARS
• Type of Device: ELECTROSURG, CUTTING & COAG ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 10686671
• MDR Text Key: 240178380
• Report Number: 2134070-2020-00012
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 10888551045117
• UDI-Public: 10888551045117
• Combination Product (y/n): N
• PMA/PMN Number: K161086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2022
• Device Model Number: HAR36R
• Device Catalogue Number: HAR36R
• Device Lot Number: 2063328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1