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

Model Number SP90-7843

Device Problem Insufficient Information (3190)

Patient Problems Excessive Tear Production (2235); Bowel Perforation (2668)

Event Date 05/09/2017

Event Type  Injury  

Event Description

Customer reported via email: instrument tore bowel during use.No further details provided.On 11may2017 additional information: can you please tell me where the device was located when the issue was noticed? during procedure.Was there any patient injury or intervention? bowel was torn but was repaired by surgeon.What was the patient¿s medical status after the event? stable.Were there any retained objects? none.Did the patient require an additional medical procedure such as an x-ray? none.What type of procedure was being performed? lap rouk-en-y??? was the procedure completed as planned? yes.Do you require further assistance? no.No further information available.

Manufacturer Narrative

(b)(4).One (1) dtouch2 debakey clamp 25mm jaw 5mm 36cm was returned as the complaint samples.The etching on the sample was noted to be legible.The lot code was noted as h09 (august 2009).The etching indicated that the sample from 2009 was repaired twice, ¿r2¿.The sample was returned intact with all parts, and no missing pieces were noted.Upon initial visual inspections the sample displayed usage marks consistent with the age.Scratches were found on the handle as well as staining on the pad printed section.A tag was placed on the sample with the word ¿sharpen¿.Further inspections were performed with the following people: a manufacturing engineer, a repairs operator, a quality inspector, and two manufacturing operators.A consensus of opinions resulted in the conclusion that the sample functioned as normal, with both the ratchet and rotation knob activating as intended.In the repairs completed on the sample, there was never a mention of the jaw being replaced, which confirms that it has been used for the duration of the sample¿s life.The overall sharpness was then examined, in which the sample was declared to have a slightly raised edge.This edge has not been an issue over the 8 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.Device history records for date code/lot codes, h09 r2 (august 2009)/ lot numbers 820902 and 820845 were reviewed: all work instructions were completed accordingly.No issues were identified.Qa inspections were performed; all inspections passed.The repair records were reviewed and nothing was included about the jaw being replaced, or dulled/sharpened.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.Previously the lot number was inadvertently reported incorrectly.

• 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: 6575096
• MDR Text Key: 75439403
• Report Number: 1038548-2017-00120
• 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: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• 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: 820902 OR 820845 H09 R2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2009
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention