MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY® CLAMP; CLAMP, CHOLANGIOGRAM

Model Number 91-5035

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

Device showed significant signs of use, instrument wore down due to normal wear and tear.

Event Description

Hospital had a cholangiogram forceps tip break during the surgical procedure.

• Brand Name: SYMMETRY® CLAMP
• Type of Device: CLAMP, CHOLANGIOGRAM
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: victoria rogers ; 3034 owen drive; antioch, TN 37013 ; 8002513000
• MDR Report Key: 7521805
• MDR Text Key: 108891670
• Report Number: 3007208013-2018-00008
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 00887482129777
• UDI-Public: 00887482129777
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/16/2018

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 Model Number: 91-5035
• Device Catalogue Number: 91-5035
• Device Lot Number: BJ1114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1