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

Model Number C4120

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2015

Event Type  malfunction  

Manufacturer Narrative

Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent 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.

Event Description

Splenic flexture for cancer - "dr (b)(6) placed atrac through trocar just as he did this he visualised the blue pad came off the atrac in the patient.Dr removed immediately with the other atrac that was inside the patient.(b)(6) scrub nurse relayed dr (b)(6)'s concern that if he hadn't seen the actual event would they then be able to detect via xray? upon visual inspection before procedure all seemed fine and no apparent damage to packaging/storage/unpacking and set up was all fine." type of intervention- "dr (b)(6) saw it as it came away and removed immediately." patient status- "stable.".

Manufacturer Narrative

Investigation summary: one grasper reposable cartridge was returned for evaluation.Upon inspection, engineering confirmed that one of the latis pads was missing from the jaw.The jaw of the detached pad had an uneven application of adhesive.A review of the manufacturing records for this lot was not performed, as no lot number was provided.The customer's experience is attributed to a manufacturing error.Training has been conducted with manufacturing to develop a heightened awareness of this incident.In accordance to 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: 5031717
• MDR Text Key: 24153888
• Report Number: 2027111-2015-00601
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/26/2015

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
• Device Operator: Other
• Device Model Number: C4120
• Device Catalogue Number: 100864001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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