MAUDE Adverse Event Report: APPLIED MEDICAL C4120, 38CM GRASPER REPOS CART, 10/BX; NWV

Model Number C4120

Device Problems Mechanical Problem (1384); Sticking (1597)

Patient Problem Bowel Perforation (2668)

Event Date 06/15/2015

Event Type  malfunction  

Event Description

Laparoscopic bowel resections- "one monday, (b)(6), during a laparoscopic resection of small bowel, primary surgeon, dr.(b)(6) noticed a bowel perforation.Perforation was discovered while she was "running the bowel." the injury was attributed to the use of the applied medical's instruments (2) direct drive reposable graspers.Dr.(b)(6) noted that the tips of the instruments may have adhered to the bowel tissue even after the jaws were open, thus tearing the tissue when surgeon pulled away the instrument.Dr.(b)(6) noted that often tips of these graspers tend to be "sticky" and don't easily let go of the tissue, even though the jaws are open.As a result of this injury, perforated portion of the bowel needed to resected and re-anastomosed.To accomplish this more time was required, lengthening the time patient was under general anesthesia and surgeon needed to use more stapling devices to perform this repair." type of intervention- needed to do a bowel resection patient status- good.Related to (b)(4).

Manufacturer Narrative

The incident device anticipated to return.A follow-up report will be provided upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.

Manufacturer Narrative

Investigation summary: we have tried to obtain the incident device for evaluation with no success.The incident product was not returned for evaluation.A review of the manufacturing records for the lot number provided revealed that the product passed all quality and manufacturing inspections.Product from lot 1237806 is no longer in stock; however, ten (10) units from another lot were used to test tissue adherence using porcine tissue.The results showed no tissue adherence following 1-3 hours of grasping.In the absence of the subject device, engineering was unable to determine the root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance and safety of its products.In accordance with 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• Brand Name: C4120, 38CM GRASPER REPOS CART, 10/BX
• Type of Device: NWV
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer (Section G): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 4913922
• MDR Text Key: 6056929
• Report Number: 2027111-2015-00447
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2015

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: Other
• Device Expiration Date: 01/21/2018
• Device Model Number: C4120
• Device Catalogue Number: 100864001
• Device Lot Number: 1237806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 07/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention