MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES UNKNOWN; GCJ

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bowel Perforation (2668)

Event Type  Injury  

Manufacturer Narrative

No product is being returned for evaluation.A follow up report will be sent upon completion of investigation.

Event Description

Procedure performed: unk.We just heard of another issue at a different account.Limited information is available at the time of the report.Additional information was received via email on (b)(6) 2018 from health system manager: there was a misunderstanding.The issue happened years ago.Additional information was received via email on (b)(6) 2018 from health system manager: the dr [] from [] had a hard time using the optics and hit bowel.Patient was fine.It was years ago.That¿s all the info i have.We are trying to talk to the surgeon but she isn¿t responding.Additional information was received via email on (b)(6) 2018 from health system manager: i have tried to gain more information but have been unsuccessful.No one remembers because it was so long ago.Additional information was received via email on (b)(6) 2018 from health system manager: i emailed on (b)(6) and called (b)(6).He was not able to give me anymore information as it "happened years ago".Reporter unable to provide details as it was so long ago.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical has reviewed the details surrounding the event and related product.At this time, applied medical is unable confirm that a product malfunction occurred.Applied medical will monitor its vigilance systems for any developing trends.

Event Description

Procedure performed: unk.Event description: we just heard of another issue at a different account.Limited information is available at the time of the report.Additional information was received via email on 05nov2018 from health system manager: there was a misunderstanding.The issue happened years ago.Additional information was received via email on 07nov2018 from health system manager: the dr [] from [] had a hard time using the optics and hit bowel.Patient was fine.It was years ago.That¿s all the info i have.We are trying to talk to the surgeon but she isn¿t responding.Additional information was received via email on 13nov2018 from health system manager: i have tried to gain more information but have been unsuccessful.No one remembers because it was so long ago.Additional information was received via email on 16nov2018 from health system manager: i emailed on oct 25th and called nov 6th.He was not able to give me anymore information as it "happened years ago." patient status: reporter unable to provide details as it was so long ago.

• Brand Name: UNKNOWN
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8135672
• MDR Text Key: 129436535
• Report Number: 2027111-2018-00453
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other