MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8301, S ALEXIS WND PROT/RET 5/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8301
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Name of procedure being performed: right hemicolectomy.Detailed description of event (b)(6).The client uses the new configuration of c8301 to take out specimen, and then the wound sheath was broken.Additional information received via email on 2mar2020 from purchasing rep: the sheath tear occurred mid-procedure, "when they pick up the specimen".There were no instruments used within the alexis.The alexis was removed and replaced with a new device to complete the case.Patient status: fine.Type of intervention: ni.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that there was a tear in the sheath.Engineering observed that the gate remnant of the inner ring, which is where the plastic enters the mold, was rough and not flush with the inner ring.Based on the condition of the returned unit, it is likely that the gate remnant on the inner ring created a hole when it came into contact with the sheath.The hole likely propagated through the sheath material when the sheath experienced stress during use.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: right hemicolectomy.Detailed description of event: hospital: (b)(6) hospital.The client uses the new configuration of c8301 to take out specimen, and then the wound sheath was broken.Additional information received via email on 2mar2020 from purchasing rep: the sheath tear occurred mid-procedure, "when they pick up the specimen".There were no instruments used within the alexis.The alexis was removed and replaced with a new device to complete the case.Patient status: fine.Type of intervention: ni.

• Brand Name: C8301, S ALEXIS WND PROT/RET 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: 9861318
• Report Number: 2027111-2020-00431
• Device Sequence Number: 2874729
• Product Code: KGW
• UDI-Device Identifier: 00607915117207
• UDI-Public: (01)00607915117207(17)221110(10)01(10)1374280
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/10/2022
• Device Model Number: C8301
• Device Catalogue Number: 100726601
• Device Lot Number: 1374280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1