MAUDE Adverse Event Report: UNKNOWN METZENBAUM SCISSORS

Catalog Number A-SIM-12-04632CC

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 09/25/2017

Event Type  Injury  

Manufacturer Narrative

The catalog and serial numbers provided by the user facility are unknown to us and we have no record of selling metzenbaum scissors to this hospital.We repeatedly requested the device to be sent to us to ascertain its identity.We also requested a po and/or invoice number to assist us in our search, but no such information was provided by the hospital contact person.The hospital contact person stated not to be able to obtain more information regarding the device or the event and provided the name, telephone number and email of a member of operating room staff for this purpose.We made repeated attempts to contact the operating room contact person to obtain more information about the patient's condition and the event, including the device's involvement.However, all attempts at direct communication by email were ignored.It was also impossible to locate the person by telephone, since this alleged member of the or staff was unknown to all the individuals we spoke to at several ors in the hospital.It has proved impossible to obtain the name of another person able to provide more information.To date we have not received the device.It has therefore not been possible to confirm whether the device is ours nor to identify the manufacturer.This complaint cannot be confirmed.

Event Description

The surgeon was using scissors on patient's skin/tissue when the scissor tip broke off.

• Brand Name: METZENBAUM SCISSORS
• Type of Device: SCISSORS
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 7042847
• MDR Text Key: 92465973
• Report Number: 2434839-2017-00001
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A-SIM-12-04632CC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2017
• Distributor Facility Aware Date: 10/18/2017
• Event Location: Hospital
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other