MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS COUPLER ACCESSORIES; FORCEPS

Catalog Number 5193-06001-010

Device Problem Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Date 01/02/2019

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that rust spots were observed on two (2) coupler forceps.The instruments were ultra-sounded, hand debris, and placed in and an automatic washer/disinfector.The reporter stated they use a neutral detergent, non-silicone lubricant and enzymatic cleaner to clean the instruments.This issue was observed prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information : two (2) devices were received for evaluation.A visual inspection was performed on the returned forceps and brownish/orange discoloration was noted.The reported problem was verified.The cause of the reported condition was undetermined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: COUPLER ACCESSORIES
• Type of Device: FORCEPS
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; saint paul MN
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8290687
• MDR Text Key: 134571798
• Report Number: 1416980-2019-00393
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5193-06001-010
• Device Lot Number: SP17H03-1242841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1