MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R47, 12X100 KII BALLOON BLUNT TIP 6/BX; GCJ

Model Number C0R47

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

The event device is anticipated to return.A follow-up report will be provided upon completion of investigation.There is no report of serious injury or death associated with this event.

Event Description

Procedure performed: laparoscopic proximal gastrectomy."this is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation." report from the sales rep: "the customer felt an inserted endoscope got stuck in the seal, particularly, the ddb during laparoscopic proximal gastrectomy procedure.Insertion and manipulation of the device deteriorated because the stretched ddb was clinging to the endoscope." initial investigation report by (b)(4) olympus."the event unit was returned to olympus and visually inspected.No visible damage was observed with the ddb, septum and shield.The unit will be returned to amr for further evaluation.(b)(4)." type of intervention: unk.Patient status: no patient injury.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Engineering attempted to replicate the complainant's experience, but was unable to recreate the drag force that was experienced by the complainant.Upon further inspection, engineering noticed that the shield, a clear internal component of the seal, had dislodged from the septum.It is likely that the shield was not secured properly within the septum during the assembly process and was dislodged when the obturator was inserted into the seal.The probability and criticality of harm resulting from this failure mode have been evaluated and were found to be at an acceptable level.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.

• Brand Name: C0R47, 12X100 KII BALLOON BLUNT TIP 6/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: jennifer scoullar ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497133904
• MDR Report Key: 6455288
• MDR Text Key: 71582302
• Report Number: 2027111-2017-01667
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915116453
• UDI-Public: (01)00607915116453(17)190819(30)01(10)1276720
• Combination Product (y/n): N
• PMA/PMN Number: K060629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/19/2019
• Device Model Number: C0R47
• Device Catalogue Number: 101246101
• Device Lot Number: 1276720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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