MAUDE Adverse Event Report: CAREFUSION, INC DEBAKEY TITANIUM TISSUE FORCEPS 7-3/4IN; CARDIOVASCULAR SURGICAL INSTRUMENT

Catalog Number CH5885-T

Device Problem Difficult to Open or Close (2921)

Patient Problem Tissue Damage (2104)

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) a follow up emdr will be submitted upon supplier evaluation or if additional information is received.(b)(4) - manufacturer was chosen as carefusion since real manufacturer avalign german specialty instruments was not available.

Event Description

Surgeon was having difficulty grasping tissue and it caused tissue damage.Customer reported that the patient was fine.

Event Description

Surgeon was having difficulty grasping tissue and it caused tissue damage.Customer reported that the patient was fine.

Manufacturer Narrative

Follow up (b)(4).Two devices were returned by the customer and forwarded to the supplier, avalign german specialty instruments, for evaluation.The instruments were manufactured in the second week of (b)(6) 2018.An investigation was performed by the supplier and determined that the blue anodized coating on the devices appeared to be wearing off and the etching was hard to read.The devices were inspected by the quality manager and found to be functioning as intended.The devices met product specifications.The two arms of the forceps were assembled together with no issues found.The inventory was checked and no defects were found with the new products.There were no issues identified with the materials or manufacturing process.A review of the device history record was performed and no issues were found during production.All processes were completed per procedure and no deficiencies were found during manufacturing, packaging and shipping.

• Brand Name: DEBAKEY TITANIUM TISSUE FORCEPS 7-3/4IN
• Type of Device: CARDIOVASCULAR SURGICAL INSTRUMENT
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 7778678
• MDR Text Key: 117156399
• Report Number: 2243072-2018-01139
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/01/2018

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 Catalogue Number: CH5885-T
• Device Lot Number: E18VIN
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 07/13/2018
• Supplement Dates FDA Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other