MAUDE Adverse Event Report: CAREFUSION, INC DTOUCH2 DEBAKEY CLAMP 25MM JAW 5MM 36CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number SP90-7843

Device Problem Torn Material (3024)

Patient Problem Laceration(s) (1946)

Event Date 04/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) on 12apr2017, writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated.If the device is evaluated a follow up will be sent.

Event Description

Sales rep reported via email: graspers had been used to remove valve; before valve removal, grasper had torn valve.Reporter states no patient harm, please confirm any additional intervention required.Second instrument reported captured in (b)(6).On 19april2017 additional information from customer: was there any patient intervention when the grasper had torn the bowel? tissue was evaluated and tear was repaired.What was the patient¿s medical status after the event? stable.What type of procedure was being performed? laparoscopic bariatric procedure.Was the procedure completed as planned? yes.

Manufacturer Narrative

(b)(4).One (1) sp90-7843 clamp device was received for evaluation for grasper tore the patient¿s bowel.Evaluation by the quality engineer, lead manufacturing technician and lead quality final technician revealed that the returned device tip was slightly raised.The jaws come as a machined part.The print says to lightly bevel out edges around entire mouth of jaw.The edges were noted to be beveled but may not have been beveled enough to customer satisfaction.According to the records the device is 5 years old and has been in the possession of the customer since (b)(6) 2013 (almost 5 years) without a complaint.We are not sure of the manner of handling and usage of the instrument during use.The device passed all the acceptance criteria for release prior to shipment to the customer.Both the quality and manufacturing lead technicians have been made aware of this reported issue.A review of the device history record (s) did not reveal non-conformances.The devices passed all acceptance criteria for release.Conclusion(s): customer - preference: according to the records the device is 5 years old and has been in the possession of the customer since february 2013 (almost 5 years) without a complaint.We are not sure of the manner of handling and usage of the instrument during use.The device passed all the acceptance criteria for release prior to shipment to the customer.Both the quality and manufacturing lead technicians have been made aware of this reported issue.Bd will continue to trend and monitor this reported issue and for this product family.

Event Description

On (b)(6) 2017 (b)(6) reported a correction, the grasper tore the patients bowel not the previously reported valve.She reported there was a barb on the grasper.

• Brand Name: DTOUCH2 DEBAKEY CLAMP 25MM JAW 5MM 36CM
• 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: 6534940
• MDR Text Key: 74120591
• Report Number: 1038548-2017-00114
• 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: consumer,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SP90-7843
• Device Lot Number: K12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 05/01/2017
• Supplement Dates Manufacturer Received: 06/26/2017
• Supplement Dates FDA Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2012
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention