MAUDE Adverse Event Report: APPLIED MEDICAL C4121, 45CM GRASPER REPOS CART, 10/BX; NWV

Model Number	C4121
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/15/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow-up report will be sent once the results have been analyzed.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.This report is to follow-up to maude report# mw5059013.
Event or Problem Description
Laparoscopic colon case - "during md's laparoscopic colon case a portion of a laparoscopic grasper tip fell off (one side of grasper tip appeared frayed and worn after it was in use).Grasping tips were both intact upon opening package.The piece was found and pulled out.Two graspers were used.Unsure which failed, so both are being reported." patient status unknown.
Additional Manufacturer Narrative
Investigation summary: the incident product was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the incident.A review of the manufacturing records indicates this lot passed all manufacturing and quality inspections.  all graspers undergo a 100% visual and functional inspection during the manufacturing and assembly process.Although the root cause of your experience could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.This report is to follow up with medwatch# mw5059013.

• Brand Name: C4121, 45CM GRASPER REPOS CART, 10/BX
• Common Device Name: NWV
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5469416
• Report Number: 2027111-2016-00176
• Device Sequence Number: 18902344
• Product Code: NWV
• UDI-Device Identifier: 00607915116873
• UDI-Public: (01)00607915116873(17)180408(30)01(10)1244657
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2016

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
• Operator of Device: Other
• Device Expiration Date: 04/08/2018
• Device Model Number: C4121
• Device Catalogue Number: 100864101
• Device Lot Number: 1244657
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/29/2016
• Supplement Report FDA Received Date: 06/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1