MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8701
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit will not return for evaluation; however, the lot number is provided.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: na.Detailed description of event: complaint (b)(4) will address event unit 1 of 2.Complaint (b)(4) will address event unit 2 of 2.This was discovered prior to surgery and there was no patient contact.When the device was pulled from the shelf it was noted that a pinhole was on the white tyvek side of the pouch on each of the units pulled.It is unknown if the same lot was pulled for both devices.Once device was discarded by the hospital and not available for return.The other unit is available for return.The hospital has third party sourcing within the hospital and the devices are removed from the outer carton and placed on the shelf by medical staff for storage.Photographs are available.Additional information was received via email on 19dec2019 from app.Med.Acct.Mgr.: 6 photos were provided.The hospital is [name] hospital account # (b)(4).Product: alexis laparoscopic system (small).1 each of product # c8701, # lot # 1338150.1 each of product # c8701, # lot # 1335750.Patient status: na (before use).Type of intervention: na.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided by the complainant.Visual inspection confirmed that there was a hole in the tyvek of the pouch.Based on the photograph provided by the complainant and the description of the event, it is likely that the reported event was caused by handling at the hospital¿s facility.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Name of procedure being performed: na.Detailed description of event: complaint (b)(4) will address event unit 1 of 2.Complaint (b)(4) will address event unit 2 of 2.This was discovered prior to surgery and there was no patient contact.When the device was pulled from the shelf it was noted that a pinhole was on the white tyvek side of the pouch on each of the units pulled.It is unknown if the same lot was pulled for both devices.Once device was discarded by the hospital and not available for return.The other unit is available for return.The hospital has third party sourcing within the hospital and the devices are removed from the outer carton and placed on the shelf by medical staff for storage.Photographs are available.Additional information was received via email on 19dec2019 from app.Med.Acct.Mgr.: 6 photos were provided the hospital is [name] hospital account # (b)(4).Product: alexis laparoscopic system (small).1 each of product # c8701, # lot # 1338150.1 each of product # c8701, # lot # 1335750.Patient status: na (before use).Type of intervention: na.

• Brand Name: C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX
• Common Device Name: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9589095
• Report Number: 2027111-2020-00313
• Device Sequence Number: 11437223
• Product Code: KGW
• UDI-Device Identifier: 00607915125714
• UDI-Public: (01)00607915125714(17)210919(30)01(10)1335750
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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: No Information
• Device Expiration Date: 09/19/2021
• Device Model Number: C8701
• Device Catalogue Number: 101135801
• Device Lot Number: 1335750
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1