MAUDE Adverse Event Report: 1392 5.9MM STRYKER SHEATH 2 WAY -NS; RIGID ENDOSCOPE SHEATH

Model Number	281392
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi:(b)(4).Investigation summary: despite several attempts for information about the device return status there has been no further information provided.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.This complaint cannot be confirmed.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the sales rep via phone that during a shoulder repair procedure the customer's 5.9mm stryker sheath 2-way is leaking due to damaged o-rings.The procedure was able to be completed with the device with no harm to the patient or delays to the case.The sales rep was not present for the case therefore could not any further information.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary = according to the information received, it was reported that during a shoulder repair procedure the customer's 5.9mm stryker sheath 2-way is leaking due to damaged o-rings.Despite several attempts for information about the device return status there has been no further information provided.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.This complaint cannot be confirmed.According to attached memo referencing to sopro-comeg, as sopro-comeg gmbh maintained all manufacturing records in their files and no relation has been held with this company since september 2017, no manufacturing record evaluation can be performed for all lots manufactured by sopro-comeg gmbh.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: 1392 5.9MM STRYKER SHEATH 2 WAY -NS
• Common Device Name: RIGID ENDOSCOPE SHEATH
• MDR Report Key: 9117773
• Report Number: 1221934-2019-58505
• Device Sequence Number: 11208402
• Product Code: HNX
• UDI-Device Identifier: 10886705016099
• UDI-Public: 10886705016099
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K951702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2018

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: Health Professional
• Device Model Number: 281392
• Device Catalogue Number: 281392
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 07/11/2021
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 07/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1