MAUDE Adverse Event Report: CAREFUSION, INC DTOUCH2 FENEST DISSECTOR 16MMJAW 5MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number SP90-7836

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).If further information becomes available a follow up medwatch will be submitted.

Event Description

The customer reported the grasper tore the bowel when grabbing onto the bowel when he was repairing during bariatric surgery.The tear was repaired by sutures and the procedure stayed laparoscopic.No other reported medical interventions.

Manufacturer Narrative

(b)(4): one (1) sp90-7836 dtouch2 fenest dissector was returned for evaluation.Evaluation by the lead manufacturing technician and quality engineer did not confirm the reported failure.Visual and functional inspection was performed and resulted in actuating rod in the handle was bent causing the device to not rotate as well.The device was still able to function and hold suture.The overall sharpness was then examined, in which the sample was declared to have no raised edges and was of the usual beveled edge.According to the records the device has been in the possession of the customer for 5 years without a repair or a complaint from the customer.This edge has also not been an issue over the 5 years this sample has been in existence.Testing was performed on muslin cloth with a pulling force.No tearing or cutting was observed on the cloth.There are many unknowns concerning the reported failure: the amount of procedures the sample has endured, the amount of usage, the amount of uses in which the sample did not cause excess trauma and the amount of wear upon the instrument.In addition, it is unknown of the user technique and the force that was applied to the tissue during the surgery which was performed.This would indicate the amount of trauma in which the cut bowel endured.As this device was found to be within specification, as a recommendation the use of a bowel clamp might be better suitable for usage since it has longer jaws with 2x3 rows of smooth teeth and is available under product numbers sp90-7845 and sp90-7846.A review of the device history record (s) did not reveal non-conformances.The devices passed all acceptance criteria for release.Conclusion(s): other- not confirmed the reported failure could not be duplicated.Bd will continue to trend and monitor this reported issue and for this product family.

• Brand Name: DTOUCH2 FENEST DISSECTOR 16MMJAW 5MM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 5175 south royal atlanta dr; tucker GA 30084
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6706149
• MDR Text Key: 79788888
• Report Number: 1038548-2017-00129
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SP90-7836
• Device Lot Number: 843985 C12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2012
• 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
• Patient Outcome(s): Required Intervention