MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0L00, 5MM DISPOSABLE SEALS, 20/BOX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0L00
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic bowel resection.Event description: cmdsnet report #: s-2491, mdip 1147-seal without stopcock.Recurring issue middle piece of black rubber became detached during use.Additional information received via email on 16jan2020 from distributor: middle piece of black rubber became detached during use.There was no apparent harm to the patient.This was reported to cmdsnet.Additional information received via email on 16jan2020 from user facility: this was a while ago so they provided what they could: the procedure performed was a laparoscopic bowel resection.The procedure was completed laparoscopically.No apparent injury to patient ¿ this was also included in the report provided to southmedic.Instrumentation being used at the time of the incident was endoscopic [] grasper.The entire component fell out.No pieces fell into patient.All pieces were removed from the surgical field and retained off.Type of intervention: all pieces were removed from the surgical field.Patient status: no apparent patient harm.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the event unit confirmed the complainant¿s experience of seal component separation.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by a grasper that was inserted through the seal subassembly in a non-axial manner or the jaws of the grasper that were in the open position when the grasper passed through the seal subassembly.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
Procedure performed: laparoscopic bowel resection.Event description: cmdsnet report #: (b)(4), mdip 1147-seal without stopcock.Recurring issue: middle piece of black rubber became detached during use.Additional information received via email on 16jan2020 from distributor: middle piece of black rubber became detached during use.There was no apparent harm to the patient.This was reported to cmdsnet.Additional information received via email on 16jan2020 from user facility: this was a while ago so they provided what they could: the procedure performed was a laparoscopic bowel resection.The procedure was completed laparoscopically.No apparent injury to patient ¿ this was also included in the report provided to southmedic.Instrumentation being used at the time of the incident was endoscopic [] grasper.The entire component fell out.No pieces fell into patient.All pieces were removed from the surgical field and retained off.Intervention: all pieces were removed from the surgical field.Patient status: no apparent patient harm.

• Brand Name: C0L00, 5MM DISPOSABLE SEALS, 20/BOX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9694296
• Report Number: 2027111-2020-00352
• Device Sequence Number: 16629835
• Product Code: GCJ
• UDI-Device Identifier: 00607915115739
• UDI-Public: (01)00607915115739(17)211212(30)01(10)1339527
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K932995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: Health Professional
• Device Expiration Date: 12/12/2021
• Device Model Number: C0L00
• Device Catalogue Number: 100323501
• Device Lot Number: 1339527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPIC WOLFE GRASPER.