MAUDE Adverse Event Report: NOVO SURGICAL INC. NOVO SURGICAL INC.; ZENITH ROCHESTER-OCHSNER FORCEPS, 1X2 TEETH, STRAIGHT, 8"" (20.3 CM)

Model Number G92723-31

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/19/2021

Event Type  malfunction  

Event Description

Novo surgical inc.Received a sus voluntary event report from the fda (report mw5101715) notifying it of a mdr submitted by the a user/facility with regards to a zenith rochester ochsner forceps, 1x2 teeth, straight, (item no.G92723-31) supplied by novo surgical.The fda correspondence was delivered via postal mail and received by novo surgical on june 26, 2021.This was the first notification to novo surgical of this complaint.The sus voluntary event report indicated that an event that happened on (b)(6) 2021, was reported to the fda, by the user facility on june 02, 2021.The event indicates a product malfunction where the tip of two novo surgical kochers were found to be broken during a surgical procedure.The sus voluntary event report from the fda (report mw5101715) was the first notification received by novo surgical of the event.No notification from the user facility was received by novo surgical prior to the sus voluntary report from the fda.

Manufacturer Narrative

Novo surgical inc.Received a sus voluntary event report from the fda (report mw5101715) notifying it of a mdr submitted by a user facility with regards to a zenith rochester ochsner forceps, 1x2 teeth, straight, (item no.G92723-31) supplied by novo surgical.This is the third sus voluntary report received for this device with same lot from the same user facility.It is unclear whether the user facility submitted duplicate reports for the same product concern.No clarification or additional information was provided by the user facility upon novo surgical's request for investigation questions.Novo surgical started its preliminary investigation by reviewing the device history records of the item for any similar complaints or non-conformities.No similar issues or non-conformities were noted for this item.No patient associated injuries were reported by the user facility.Additional information was requested from the user facility and the reported devices were requested to be returned for evaluation.However, to this date, the user facility has not been willing to return the items back for evaluation.In addition to this, specific information about the product associated usage or its malfunction, were not provided by the user facility.With little to no information provided by the user facility, novo surgical performed its internal investigation by sending out a piece of the concerned device with the same reported lot to an independent laboratory for hardness testing at the specific point of breakage.The hardness survey was conducted and compared against the astm e384-17 standard with no reported non-conformities or issues with the tested device.With no manufacturing defects with the item, novo surgical suspects the breakage to be deemed to have occurred due to a user related error.At this time, novo surgical identifies no corrective and/or preventive actions to be taken.If additional information affective the investigation, is received from the user facility, or if the affected device is returned for evaluation, a follow up report will be submitted.

• Brand Name: NOVO SURGICAL INC.
• Type of Device: ZENITH ROCHESTER-OCHSNER FORCEPS, 1X2 TEETH, STRAIGHT, 8"" (20.3 CM)
• Manufacturer (Section D): NOVO SURGICAL INC.; 700 commerce drive; oakbrook IL 60523
• MDR Report Key: 12229619
• MDR Text Key: 280896919
• Report Number: 3008770252-2021-00006
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 07/26/2021

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?: No
• Device Operator: No Information
• Device Model Number: G92723-31
• Device Catalogue Number: G92723-31
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2021
• Initial Date FDA Received: 07/27/2021
• Patient Sequence Number: 1